MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

MEDTRONIC SOFAMOR DANEK USA, INC METRX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 9569567

Device Problems Break (1069); Fracture (1260)

Patient Problems Coagulation Disorder (1779); Embolus (1830); Encephalopathy (1833); Extravasation (1842); Fistula (1862); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Neuropathy (1983); Pain (1994); Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)

Event Date 05/01/2017

Event Type Injury

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during surgery, a portion of the jaw of the micropituitary fractured and remained in the patient.The patient punctured the iliac artery during the procedure.It is unknown whether the damage to the iliac artery occurred as a result of the breakage.The product came in contact with the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during surgery, a portion of the jaw of the micropituitary fractured and remained in the patient.Patient's iliac artery got punctured during the procedure.It is unknown whether the damage to the iliac artery occurred as a result of the breakage.The product came in contact with the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2017: the patient was pre-operatively diagnosed with l3-l4, l4-l5 disk herniation.Lumbar radiculopathy and underwent the following procedures: right l3-l4 and l4-l5 microdisectomy.Application of 80 mg of topical depo-medrol epidural steroid.Use of c-arm fluoroscopy.Use of operating microscope.Complications: fractured pituitary rongeur into l4-5 disk space.Intraoperative hypotension.(b)(6) 2017: the patient underwent the ct of abdomen/ pelvis.Impression: traumatic injury causing pseudoaneurysm of the right common iliac artery and fistula between the right common iliac artery and ivc.Retroperitoneal hematoma.On (b)(6) 2017: the patient underwent ct angiogram of pelvis abdomen.Impression: continued focal extravasation/pseudoaneurysm of the proximal right iliac artery with rapid passage into the venous system heading in the vena cava.The size of the current pseudoaneurysm/focus of extravasation is slightly smaller than earlier examination.Increasing retroperitoneal and pelvic haematoma.On (b)(6) 2017: the patient was diagnosed with ivc thrombus.Retroperitoneal hematoma.Illiac artery extravasation.On (b)(6) 2017: the patient underwent ct of abdomen/pelvis wo/w contrast.Impressions: extravasation of contrast adjacent to the stented portion of the proximal right common iliac artery.This finding is concerning for ongoing arterial bleeding.I suspect the degree of bleeding has been limited by the presence of two overlapping right common iliac artery stents.Extensive thrombus in the inferior vena cava.Large retroperitoneal hematoma.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Radiographic image review result: in intra-op image and post-op ct image for l4-5 artery minimally invasive discectomy is shown.By report one of the pituitary rongeurs broke during the procedure.On ct imaging the metallic fragment appears anterior to the disc space and a hematoma, pseudoaneurysm of the iliac artery is present.This is likely an injury sustained to the vessel once the anterior artery was violated with the instrument.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During surgery on (b)(6) 2017, a part of the jaw of the rongeur/upbiting micro pituitary broke off, resulting in a traumatic injury and pseudoaneurysm of the right common iliac artery, and a fistula between the right common iliac artery and the inferior vena cava with retroperitoneal hemorrhage accompanied by loss of approximately 800 ml of blood, with severe hypotension.The surgical procedure was eventually aborted, and patient was then emergently transferred to new facility (b)(6) for treatment of her life threatening intra-operative injury and bleeding.The patient underwent a surgical procedure consisting of ultrasound guided bilateral common femoral percutaneous access; aortogram; venogram; with right common iliac stent placement x 2; bilateral femoral angiogram; 8 french angio-seal closure of the right femoral access; mynx closure of the left femoral access; removal of the right femoral vein triple lumen catheter.On (b)(6) 2017, while at new facility, patient underwent a second surgical procedure consisting of an aortogram, angioplasty and stent of right iliac artery with covered stent graft; cannulation of lumbar artery with micro catheter and microwire; coil embolization of lumbar artery with closure of both groins.On (b)(6) 2017, while at new facility, patient underwent a third surgical procedure consisting of a left iliac artery angioplasty and stent and coil embolization of the lumbar artery.As a direct and proximate result of the conduct set forth, allegedly, the patient has suffered as follows: patient experienced massive hemorrhage; patient was required to undergo numerous surgeries; patient experienced a coagulopathy resulting in saddle pulmonary embolus, retroperitoneal hematoma, inferior vena cava thrombus with extravasation of the proximal right common iliac artery, retroperitoneal hematoma, and right heart strain requiring surgical interventions and the placement of an ivc filter; patient developed heparin induced thrombocytopenia; patient developed altered mental status and encephalopathy; patient developed a hypotensive crisis; patient continued, and continues, to suffer debilitating low back pain due to the aborted surgery and ongoing inability to have that procedure completed, patient developed cognitive and physical disabilities due to the severe vascular injury and related sequela.Reportedly, the patient has experienced physical pain and suffering, permanent emotional and physical pain and suffering, permanent and severe loss of the enjoyment of life as well as past, present and future wage loss and a diminished earning capacity.

Event Description

On (b)(6) 2001: the patient underwent mri lumbar spine without contrast.Impressions: negative mri of the lumbosacral spine.On (b)(6) 2003: the patient underwent spine cervical min 4 views.Impressions: 1) degenerative changes lower cervical with moderate neural foraminal encroachment c5-6, c6-7 right.2) scoliosis convex right.On (b)(6) 2010: the patient underwent spine cervical min 4 views.Impressions: mild to moderate degenerative changes of the cervical spine.On (b)(6) 2012: the patient underwent mri cervical spine without contrast.Impressions: 1) bilateral foraminal narrowing at c3-c4.2) bilateral foraminal narrowing at c4-c5 worsen on the right.3) bilateral foraminal narrowing at c5-c6 much worse on the right.4) spondylitic changes c6-c7 with borderline spinal stenosis with effacement of ventral subarachnoid space.The patient also underwent mri lumbar spine without contrast.Impressions: grossly normal mri through the lumbosacral spine without significant interval change compared to the prior study.On (b)(6) 2015: the patient underwent mri lumbar spine without contrast.Impressions: no disc herniations identified.Minimal degenerative facet changes lower lumbar spine.Small probable right renal cyst.On (b)(6) 2015: mri of the lumbar spine revealed mild degenerative facet changes without neural, foraminal, or central stenosis.On (b)(6)2015: the patient was pre-diagnosed with lumbalgia and lumbar facet syndrome and underwent following procedure lumbar medial branch nerve blocks with fluoroscopy at bilateral l2, l3 l4 and l5.As per op notes: fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site.Via an oblique cephalad tilt, the corresponding juncture of the superior articular process and transverse process were identified at the above stated levels.Local anesthetic wheals were raised using lidocaine 1% 10 ml.A 22-gauge 3.5-inch spinal needle was advanced to each respective target site.Needle tip positioning was confirmed and adjusted via oblique, ap, and lateral fluoroscopic imaging.Contrast dye was not required.On (b)(6) 2015: the patient was diagnosed with sacroiliac joint derangement and underwent bilateral sacroiliac joints steroid injections with fluoroscopy.As per op notes, "fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site.The fluoroscope was lined up with the above stated sacroiliac joints.Local anesthetic wheals were raised using lidocaine 1% 10 ml.A 22-gauge 3.5-inch spinal needle was advanced into the caudal tip of the above stated sacroiliac joint area(s) under direct fluoroscopic vision and control.Contrast due was used.Omnipaque 240 mg/ml was injected and showed an arthrogram.There was no evidence of intravascular flow pattern.It appeared to follow the characteristic pattern of the sacroiliac joints.Aspiration was negative for blood or csf.I then injected a mixture of traimcinolone preservative free 40 mg and marcaine 0.25% preservative free 8 ml demonstrating a good washout of contrast on the fluoroscopic image.The patient was pre-diagnosed with lumbalgia and lumbar radiculopathy and underwent lumbar transforaminal epidural steroid injections at bilateral l4-l5 with fluoroscopy.As per op notes: fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site.The fluoroscope was lined up with the above stated levels.Local anesthetic wheals were raised using lidocaine 1% 10 ml.A 22-gauge 3.5-inch spinal needle was advanced into the neural foramin via lateral oblique view under fluoroscopy at the above stated levels.Contrast dye was used.Omnipaque 240 mg/ml 4 ml was injected to confirm epidural spread under fluoroscopy at the above stated levels.Aspiration was negative for blood or csf.There was no parethesias with needle placement.I then administered a total amount of triamcinolone preservative free 40 mg and preservative free saline 2 ml and marcaine 0.25% preservative free 2 ml." on (b)(6) 2015: mri of the cervical spine revealed at c3-c4 bilateral foraminal narrowing, at c4-c5 foraminal narrowing and disc bulge and also at c5-c6 bilateral foraminal narrowing as well.On (b)(6) 2015: the patient underwent mri spine cervical without contrast: impression: multilevel degenerative disc disease.Worsening central stenosis at c3-c4 secondary to broad herniation.Stable central and foraminal stenosis at c4-c5, c5-c6 and at c6-c7.On (b)(6) 2015: the patient was pre-diagnosed with lumbalgia and lumbar radiculopathy and underwent lumbar transforaminal epidural steroid injections at bilateral l4-l5 and bilateral l5-s1 with fluoroscopy.On (b)(6) 2015: diagnostics emg performed bilateral upper extremities.Revealed evidence of right c4 and left c5 radiculopathy.No evidence of carpal tunnel syndrome bilaterally.On (b)(6) 2015: x-rays of the cervical spine with flexion and extension views was reviewed.There was no evidence of dynamic instability with flexion and extension views.There is multilevel osteophytes noted with joint hypertrophy resulting in severe canal stenosis at c4- c5, c5-c6, c6-c7, moderate stenosis at c3-c4.The patient underwent spine cervical 4 views.Impressions: multilevel degenerative change of the cervical spine with neural foraminal encroachment.No evidence of instability.On (b)(6) 2016: the patient was pre- operatively diagnosed with lumbalgia and lumbar facet syndrome.The patient underwent the following procedure- lumbar radiofrequency ablation of the medial branch nerves with fluroscopy at bilateral l5 and s1.As per op notes: an iv was placed and then the patient was brought into the procedure suite.The heart rate and pulse oximetry were monitored throughout the procedure, as a pulse oximeter machine was left in place t n the patient¿s finger.The patient was placed on a cardiac monitor throughout the procedure.The patient was placed in a prone position.Utilizing strict sterile technique, the skin was painted in an eccentric circular manner three limes with duraprep and droped in a sterile fashion.The procedure tray was then prepared and appropriate drugs were drawn up.The fluoroscoplc guidance was utilized in order to anatomically determine the proposed injection sites.Lidocaine 1% of 8 ml was injected in the skin and subcutaneous tissue.Subsequently 10 cm 20 gauge radiofrequency needles with a 10 mm active tip were advanced through the skin utilizing a tunnel approach until the angle of the transverse processes and sap was encountered with the tip of the needle.Ap, oblique, and i lateral fluoroscopy confirmed appropriate positioning of the needle at the appropriate levels.At each level, i performed motor stimulation at 2hz upto 3 volts, which showed paraspinal muscle movement but no referral to the leg.I injected lidocaine 1 % 1 ml at each level prior to lesioning.Radiofrequency lesions were performed at the medial branches of the above stated levels at 80 degrees celsius for 90 seconds.Subsequently, i injected at total amount of sensorcaine 0.25% preservative free 4 ml with triamcinolone preservative free 40 mg.The patient tolerated the procedure well and was transferred to the recovery room.The patient was provided with appointment at the office in 2 weeks or earliest if necessary.The patient was post- operatively diagnosed with lumbalgia and lumbar facet syndrome.On (b)(6) 2016: the patient came for follow up visit.The patient denies any progressive weakness of the upper or lower extremities, denies any difficulty with fine motor skills.No trouble buttoning buttons or change in her penmanship.The patient states that her neck pain is increased with any increased physical activity such as reaching.The patient states that her neck pain is significantly worse than her low back pain.The patient reports that she had rfa bilateral l5-s1 level.The patient reports significant improvement in the left side pain, stating that the right l5-s1 rfa was of no benefit.The patient plans to follow up with pain management for repeat procedure.On (b)(6) 2016:mri of lumbar spine without contrast: degenerative facet changes on (b)(6) 2016: the patient underwent 11 intraoperative fluoroscopic images of the cervical spine.57 seconds of fluoroscopic time utilized.Impression: intraoperative fluoroscopy provided for anterior fusion of the mid cervical spine.Correlation with operation recommended.On (b)(6) 2016as per op notes: patient taken to the operating room.She was intubated under general endotracheal anesthesia without complication.She was admitted emergently due to worsening myelopathy with progressive weakness and falls.She had evidence of c3-4 anterolisthesis in c3-4 and-5, worse than c5-6 and c6-7 disk herniations.I elected to do the c3-4 and c4-5 levels.There was evidence of cord signal behind these disk space.I advised her that there is a risk that she would need the other 2 levels addressed at some point in the suture.After intubation, she was positioned supine on the operating table.All pressure points were carefully padded.She received ancef for antibiotics.The shoulders and chest were draped down to exposed skin fold.The left- sided neck was prepped and draped in standard sterile fashion.Lateral c-arm fluoroscopy was used to localize the c3-4 and c4-5 disk spaces.After a dedicated time-out, we planned the incision within the skin fold using a #15 scalpel blade.The incision was made.Dissection proceeded through dermis and subcutaneous tissue with monopolar cautery.The platysmal layer was elevated using metzenbaum scissors and dissected through.I dissected a plane medial to the sternocleidomastoid, medial to the carotid sheath, onto the anterior cervical spine.Trachea and esophagus were retracted medially.Bipolar cautery was used for meticulous hemostasis.The prevertebral fascia was dissected, evaluated, and dissected away.A spinal needle was placed into the c4-5 disk space for lateral c-arm fluoroscopic confirmation of the level.I then used monopolar cautery to dissect off the longus coli out bilaterally.Both disk spaces were dissected.I placed a retractor and worked initially at the c3-4 level.I placed 12 mm caspar pins under fluoroscopic guidance.I had the anesthesiologist deflate and reinflate the endotracheal cuff to prevent any tension on the recurrent laryngeal nerve.I then brought in the operating microscope.I fashioned an extensive c3-4 diskectomy using a combination of straight and angled curette, kerrison rongeur, followed by the midas drill to shave off cauterized endplate back to bleeding bony endplate.The posterior anulus and posterior logical ligament were elevated using a nerve hook and removed using kerrison rongeur.There was a significant subligamentous disk herniation which was identified.The central canal and bilateral c4 nerve roots were decompressed widely using kerrison rongeur.There was excellent decompression, confirming free passage of the nerve hook rostrally, caudally, and along the foramina bilaterally.I achieved excellent hemostasis using bipolar cautery and packing with suriflo, which was irrigated out.I then placed a 5.5 mm cage filled with allograft and biosphere bioglass under fluoroscopic guidance.I then worked at the c4-5 level, repositioned the retractors.I brought in the operating microscope and fashioned diskectomy in similar fashion.There was significant central and bilateral foraminal stenosis noted, with right greater left foraminal stenosis appreciated at the c4-5 level as well.The posterior longitudinal ligament was removed and the wide bilateral foraminotomy and decompression was carried out.Upon confirmation of an excellent decompression, i achieved meticulous hemostasis in similar fashion using bipolar cautery and packing with surgiflo, which was irrigated out.I then again placed another 5.5 mm cage, placed under fluoroscopic guidance.It was quite challenging to get the cage to completely seat flush with the vertebral body.Under lateral c- arm fluoroscopy, i felt that it was in an acceptable position and recessed as much as humanly possible, despite the use of caspar pins and cervical traction.I then removed the casper pins and placed bone wax in the bleeding vertebral defects.I then used and awl, followed by placement of 15 mm screws into the c3, c4, c5 vertebral bodies.There was excellent purchase with all screws.Final ap and lateral fluoroscopic imaging demonstrated excellent placement of the hardware.Final motor evoked potentials and somatosensory evoked potentials, were all stable.I then obtained meticulous hemostasis using bipolar cautery and packing with surgiflo, which was irrigated out.Upon confirmation of meticulous hemostasis, i elected to tunnel a drain inferiorly.It was a very challenging dissection due to the depth of the patient's neck.I then proceeded to close the platysma layer using a running 4-0 vicryl suture for reapproximation of platysma.A running 4-0 monocryl suture was used for.Subcu closure of skin.Drapes were then removed.The wound was washed and dried.Sterile dermabond was placed for dressing.The patient was then placed in a collar.She was then taken off the table, awoken, and extubated without complication.There were no complications.All sponge and needle counts correct.On (b)(6) 2016: the patient underwent xr spine.Impressions: intraoperative fluoroscopy provided for anterior fusion of the mid cervical spine.Correlation with operative report recommended.On (b)(6) 2016: the patient was diagnosed with cervical radiculopathy and underwent c3-5 anterior cervical discectomy and fusion surgery.Impressions: this is a negative neurophysiologic intraoperative study demonstrating no significant events, changes, or data.The emg noted on the deltoids bilat was likely due to mechanical stimulation due to cage placement and nerve man ipulation.On (b)(6) 2016: the patient came for post-op visit.On (b)(6) 2016, the patient underwent a c3-c4, c4-c5 acdf.The patient continues to wear cervical collar at all times.The patient states she has improved neck pain, decreased radicular symptoms in bilateral upper extremities.The patient continues to wear cervical collar at nighttime, but notes improved sleep.The patient has had difficulty in the last several days getting her prescription of pain medications approved by insurance.The patient states that today she is in significant pain, only taking tylenol.The patient denies any numbness or weakness of the upper or lower extremities.The patient states she is tolerating a soft diet, no difficulty swallowing.No difficulty with phonation.The patient is doing well postoperatively.On (b)(6) 2016: the patient was diagnosed with lumbalgia and lumbar radiculopathy and underwent radiofrequency ablation of the peripheral nerve with fluoroscopy.As per op notes: the fluoroscope guidance was utilized in order to anatomically determine the propsed injection sites.Lidocaine 1% 8 ml was injected in the skin and subcutaneous tissue.Subsequently, a 10 cm 20-guage radiofrequency needle with a 10 mm active tip was advanced through the skin and positioned in close approximation to the dorsal root ganglion.On fluoroscopy, this corresponded to the dorsal0- cranial quadrant of the intervertebral on lateral view and on anteroposterior view, and the ti[p was located midway into the pedicle coloumn.At the point, a total amount of omnipaque 240 mg/ml 8 ml was injected along the bilateral l4 and bilateral l5 dorsal root ganglion to identify correct placement of the needle tip.There was no evidence of vascular uptake.At each level, i performed motor stimulation at 2 hz up tp 3 volt which showed reproducible paresthesias concordant to the usual chronic pain distribution.Radiofrequency lesioning was then carried out at bilateral l4 and bilateral l5.Subsequently, i injected a total amount of triamcinolene preservative free 80 mg and sensorcaine preservative free 0.25% 2 ml with saline preservative free 6 ml after negative aspiration.On (b)(6) 2016: the patient underwent lumbosacral spine with oblique views.Impressions: mild degenerative changes.The patient underwent cervical spine ct.Impressions: no evidence of actual fracture or dislocation.Degenerative changes.On (b)(6) 2016: the patient came for post-op visit for c3-4, c4-5 acdf.She reports that she continues with some residual neck pain and especially left shoulder pain.She continues to take vicodin for symptom alleviation.She has worn her external bone growth stimulator for approximately one month.She had a fall on tuesday, which did not exacerbate her symptoms, but she reported to (b)(6) for x-rays, which are not present at today's visit.On (b)(6) 2016: the patient was diagnosed with lumbalgia and lumbar radiculopathy and underwent lumbar transforaminal epidural steroid injections at right l4-l5 and right l5-s1 with fluoroscopy.As per op notes: fluoroscopic guidance was utilized in order to anatomically determine the proposed injection sites at right l4-l5 and l5-s1.The fluoro scope was lined up with the spine at the above stated levels.Local anesthetic whelas were raised using lidocaine 1% 10 ml.A 20 gauge 6 inch spinal needle was advanced into the neural foramin via lateral oblique view under fluoroscopy at the above stated levels.Contrast dye was used.Omnipaque 240 mg/ml 4 ml was injected to confirm epidural spread under fluoroscopy at the above stated levels.On (b)(6) 2016: the patient underwent mr lumbar spine without and with contrast.Impressions: 1.Extensive metal artifact obscuring l4 and l5 vertebral bodies and spinal canal; a piece of surgical metal reportedly broke and remains inside the patient.2.At l3-l4, there may be a small right foraminal disk protrusion and mild bilateral facet hypertrophy with mild right neuroforaminal stenosis without significant spinal canal stenosis.The patient underwent cervical spine x-rays(2 views of the cervical spine were obtained).Impressions: anterior fusion and diskogenic changes.On (b)(6) 2016: patient was pre-operatively diagnosed with lumbalgia and lumbar herniated nucleus pulposus without myelopathy and underwent lumbar discography with fluoroscopy surgery.As per op notes: an iv was placed and then the patient was brought into the procedure suite.The patient was given ancef 1 gram prior to the procedure.The heart rate and pulse oximetry were monitored throughout the procedure, as a pulse oximeter machine was left in place t n the patient¿s finger.The patient was placed on a cardiac monitor throughout the procedure.The patient was placed in a prone position.Utilizing strict sterile technique, the skin was painted in an eccentric circular manner three limes with duraprep and droped in a sterile fashion.The procedure tray was then prepared and appropriate drugs were drawn up.Prior to the procedure, the image intensifier was enclosed in a sterile cover.I scrubbed utilizing an easy scrub povidone iodine scrub brush and sponge.After drying with a sterile towel, i put on surgical gloves, gown, cap, and mask.The patient was then covered with a full body drape.All assistants wore masks and caps.Discography was performed by using a left- sided approach at the l3-4, l4-5, and l5-s1 level.Local anesthetic wheels were raised using lidocaine 1% 10 ml.Subsequently, a 20-gauge, 6 inch introducer needle was slowly advanced utilizing a tunnel approach down the axis of the x-ray beam at the above stated le vels.Using several short- controlled thrusts with concomitant pulsed fluoroscopy, the spinal needle was steered down to its target until it reached the disc.Depth was gauged utilizing lateral fluoroscopic views.Once all introducer needles were appropriately pl aced near the disc margins, 25- gauge, 8-inch spinal needles were inserted into the discs.The above stated discs were injected with a total amount of omnipaque 240 mg/ml 8 ml and ancef 1 g.All needles were removed.The patient was brought to the recovery room and monitored until discharge.Overall, the patient tolerated the procedure well without any complications.The patient was advised to schedule a follow-up appointment at the office within a week or earlier if necessary.On (b)(6) 2016: patient came for follow up visit.On (b)(6) 2016: mri of cervical spine without contrast: disc herniations and uv joint osteophytes at c3-4, c4-5, c5-6, and c6-7.C5-6 rightward herniation.Mri lumbar spine without contrast : degenerative facet changes.On (b)(6) 2016: the was diagnosed with lumbalgia and lumbar spondylosis without radiculopathy or myelopathy and underwent lumbar radiofrequency ablation of the medial branch nerves with fluoroscopy at right l2, l3, l4 and l5.As per op notes: the fluoroscopic guidance was utilized in order to anatomically determine the proposed injection sites at right l2, l3, l4,and l5.Lidocaine 1% 8 ml was injected in the skin and subcutaneous tissue.Subsequently 10 cm 20 guage radiofrequency needles with a 10 mm active tip were advanced through the skin utilizing a tunnel approach until the angle of the transverse processes and sap was encountered with the tip of the needle.Ap, oblique, and lateral fluoroscopy confirmed appropriate positioning of the needle at the appropriate levels.At each level right l2,l3,l4 and l5 i performed motor stimulation at 2 hz up to 3 volts which showed paraspinal muscle movement but no referral to the leg.I injected lidocaine 1% 0.5 ml at each level prior to lesioning.Radiofrequency lesions were performed at the medial braches of right l2,l3,l4 and l5 at 80 degrees celsius for 90 seconds.Subsequently , i injected at total amount of sensorcaine 0.25% preservative free 4 ml with triamcinolone preservative free 40 mg.On (b)(6) 2016: patient came for follow up visit after 7 months post-operatively.Patient reports 90 % benefit from her cervical fusion at c3-c4 and c4-c5 levels.She continues to have back pain radiating to her right leg.She had radiofrequency procedure performed last week with benefit lasting only several days.She did undergo a lumbar discogram, which i reviewed the results of.Dr.(b)(6) had performed the discogram on (b)(6) 2016, with evidence of positive concordant pain at the l3-l4 and l4-l5 levels.She did not bring the ct available for review today.She continues to take dilaudid for relief of her pain.By her report, her ct discogram was positive for disc degeneration at l3-l4 and at l5-s1, with evidence of facet hypertrophy at l5-s1.On (b)(6) 2018: the patient came for follow up visit.On (b)(6) 2018: the patient came for follow up visit.The patient was diagnosed with anoxic brain injury.On (b)(6) 2019: the patient was discharged from the hospital.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

(b)(6) 2008: the patient underwent mri l spine.Impressions: minimal lumbar spondylosis.(b)(6) 2016: the patient was pre-diagnosed with (1.) cervical myelopathy (2.) c3-4, c4-5, c5-6, c6-7, disk herniations and underwent following procedures: 1.) c3-4, c4-5 anterior cervical diskectomy for decompression, with bilateral anterior osteophytectomy 2.) c3-4 and c4-5 anterior cervical diskectomy and fusion using centinel 0.5 mm x 14 mm titanium coated midline to interbody cages 3.) anterior cervical instrumentation, c3 to c5 using centinel vertebral screw fixation 4.) use of bacterin osteosponge for allograft 5.) use of biosphere bioglass 6.) use of operating microscope 7.) use of c-arm fluoroscopy.(b)(6) 2020: the patient was admitted to hospital.(b)(6) 2020: the patient was discharged from hospital.

Manufacturer Narrative

Additional information: b5, b6 <(>&<)> b7 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit and says that she is going to receive an injection for back pain next week and hopes that she will be able to return to work by 20th feb.Interventions used: psycho-education and structured problem solving.(b)(6) 2018: the patient came for follow up visit.Therapist provided support; encouraged her to continue utilizing union to help her negotiate with employer.Interventions used: structured problem solving and supportive reflection.(b)(6) 2018: the patient came for follow up visit.Client will resolve her issues around medical problems; client will identify coping strategy to deal with medical complications.(b)(6) 2018: the patient came for follow up visit and said she was in pain today due to back and leg pain.She is deal with pain without the use of narcotics, but she did need to take pain medication today.Interventions used: structured problem solving and supportive reflection.(b)(6) 2018: the patient came for follow up visit.Interventions used: interactive feedback and structured problem solving.(b)(6) 2018: the patient came for follow up visit.Interventions used: exploration of emotions and interactive feedback.(b)(6) 2018: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and supportive reflection (b)(6) 2018: the patient came for follow up visit.Interventions used: psycho-education and structured problem solving.(b)(6) 2018: the patient came for follow up visit and said she contracted pneumonia and was hospitalized last week.Says she is trying to recover and wilt likely apply for long term disability as she is unable to work a full 8 hour shift at job.Interventions used: interpersonal resolutions and supportive reflection.04 sep 2018: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and supportive reflection (b)(6) 2018: the patient came for follow up visit and diagnosis with depressive disorder due to another medical condition, with depressive features.Interventions used: interactive feedback, interpersonal resolutions, and supportive reflection.(b)(6) 2018: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and psycho-education (b)(6) 2018: the patient came for follow up visit.Interventions used: psycho-education, review of treatment plan/progress, and structured problem solving.(b)(6) 2018: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, psycho-education, structured problem solving, and supportive reflection.(b)(6) 2018: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, psycho-education, structured problem solving, and supportive reflection.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.Interventions used: interactive feedback and psycho-education.(b)(6) 2018: the patient came for follow up visit.Interventions used: guided imagery, psycho-education, and structured problem solving.(b)(6) 2019: the patient came for follow up visit.Interventions used: psycho-education, structured problem solving, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions and interpersonal resolutions.(b)(6) 2019: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, structured problem solving, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: psycho-education, relaxation/deep breathing, and structured problem solving.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, and psycho-education.(b)(6) 2019: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, review of treatment plan/progress, and role-play/behavtoral rehearsal.(b)(6) 2019: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and psycho-education.(b)(6) 2019: the patient came for follow up visit.Interventions used: interactive feedback, psycho-education, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: guided imagery and psycho-education.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, and structured problem solving.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions and exploration of relationship patterns.(b)(6) 2019: the patient came for follow up visit.Interventions used: psycho-education, structured problem solving, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, and interactive feedback.(b)(6) 2019: the patient came for follow up visit.Interventions used: psycho-education, structured problem solving, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and psycho-education.(b)(6) 2019: the patient came for follow up visit.Interventions used: guided imagery, interpersonal resolutions, psycho-education, structured problem solving, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and structured problem solving.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, and interpersonal resolutions.(b)(6) 2019: the patient came for follow up visit.Interventions used: psycho-education, structured problem solving, and supportive reflection.(b)(6) 2019: the patient came for follow up visit.Interventions used: exploration of coping patterns and psycho-education.(b)(6) 2020: the patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, and structured problem solving.(b)(6) 2020: the patient came for follow up visit.Interventions used: guided imagery, psycho-education, relaxation/deep breathing, and review of treatment plan/progress.(b)(6) 2020: the patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, and interpersonal resolutions.(b)(6) 2020: the patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and structured problem solving.(b)(6) 2020: the patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, structured problem solving, and symptom management.(b)(6) 2020: the patient came for follow up visit.Interventions used: psycho-education and relaxation/deep breathing.

Manufacturer Narrative

Additional information: b5 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported per patient's medical records that on: 01 may 2017: as per op notes, ¿the back was prepped and draped in a standard sterile fashion.After taking a time-out, i used a spinal needle guided by c- arm fluoroscopy to localize the l3-4 and l4-5 disk spaces.A middle incision was planned.Local anesthetic consisting of 0.5% marcaine and 1% lidocaine with epinephrine was infiltrated subcutaneously.The local anesthetic was mixed in a 1:1 fashion.I made an incision using a 15-scalpel blade.I dissected through the dermis and subcutaneously tissues using monopolar cautery.Self- retaining retractors were placed.I infiltrated the lumbodorsal fascia with local anesthetic for a block.I made small openings in the fascia bilaterally at l3-4 and l4-5.I worked initially at the right l4-5 followed by the right l3-4 level.I dilated tubular retractors.I dilated the paraspinous muscle and fascia using tubular retractors and docked at the laminofacet junction, initially at l4-5 followed by l3-4.An 8-mm x 18 mm tubular retractor was placed.This retractor was to the cable mouth.I brought in the operating microscope.I cauterized any residual paraspinous muscle overfying the lamina and facet joint.I fashioned the right l4-5 hemilaminotomy using midas drill.The bony decompression was completed using (b)(6) rongeur.There was significant foraminal stenosis appreciated.I mobilized the l5 nerve root medially.I cauterized the epidural veins using bipolar cautery.There was significant amount of epidural bleeding superficially, which was readily controlled.I used microscissors followed by placement of an 11 blade to fashion the annulotomy.I fashioned extensive l4-5 diskectomy.There was no significant bleeding from the disk space.During the course of removing the disk, i noted that the superior portion of the up-angled micro pituitary rongeur had fractured off.An x-ray was obtained, which demonstrated that the pituitary rongeur was in the anterior disc space.I did not feel it was safe to retrieve.It was seated well anteriorly in the disk space and i did not feel that it was at risk extruding the nerve roots.I then achieved meticulous hemostasis using bipolar cautery and packing with surgiflo which was irrigated out.There was absolutely no bleeding at this juncture.There was an excellent decompression of the nerve root, and the nerve root.The retractor was removed.I then fashioned the paraspinous muscle at the l3-4 disk space fashioned the right l3-4 hemiloaminotomy in a similar fashion using midas drill and (b)(6) to complete the bony decompression.I mobilized the l4 nerve root medially.I fashioned the cruciate incision through the disk using # 11- scalpel blade.I fashioned an extensive discectomy using down-angled curette and pituitary rongeur.There was some bleeding from an epidermal vein just ventral to the l4 nerve root and no bleeding from within the disk space.I achieved an excellent decompression confirmed by free passage of the woodson elevator.There was no evidence of csf leak or dural tear.I t hen irrigated the wound and placed depo-medrol.I removed the retractor too.At this juncture, the anesthesiologist around 9:45 a.M.Noted that there was a drop-in blood pressure.I had noted that there was approx.800 ml of blood all from the epidural veins.We elected to stop the procedure at this time and come back another day for the left side.I proceeded to close the wound using interrupted 0 vicryl suture for re-approximation of the fascia followed by interrupted 3-0 vicryl suture for re-approximation of the debris followed by running 4-0 monocryl suture for closure of the skin.The drapes were removed.The wound was washed and dried.Sterile mastisol followed by steri-strips were applied.A sterile dressing was applied.The patient was then transferred of off the operating table.At this juncture the blood pressure started dropping again.The patient received additional fluid and pressors.The anesthesiologist had extubated the patient and she was interacting and following commands.She was moving all four extremities.However, we were concerned for the ongoing continuing dropping in the blood pressure which had stabilized upto 110/70 with fluids and subsequently dropped.This was surprising given that her hemoglobin was 13.She also appeared pale recommended that we place additional tv access for fluids.I recommended that we place additional tv access fluids.I recommended transfer to the hospital for further monitoring and for checking her blood levels.The patient was post-operatively diagnosed with (i) pulmonary embolism (ii) saddle embolus (iii) injury of iliac artery (iv) anemia (v) thrombocytopenia (vi) obesity (vii) hit (heparin induced thrombocytopenia) (viii) atrial fibrillation (ix) pain of lower extremity.¿ (b)(6) 2017: the patient was discharged from the hospital.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.X-ray taken today reveals substantial degeneration throughout with rongeur fragment noted at anterior lateral l4-5 disc space.(b)(6) 2017: the patient underwent mr lumbar spine without and with contrast.Impressions: extensive metal artifact obscuring l4 and l5 vertebral bodies and spinal canal, a piece of surgical metal reportedly broke and remains inside the patient.At l3-l4, there may be small right foraminal disk protrusion and mild bilateral facet hypertrophy with mild right neuroforaminal stenosis without significant spinal canal stenosis.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: patient was admitted to hospital and got discharged on (b)(6) 2017.Impressions: 1.Acute on chronic low back pain secondary to lumbar radiculopathy, myofascial pain, and neuropathic pain.2.Chronic opioid therapy.3.Failed back surgery syndrome.(b)(6) 2017: patient was admitted to the facility and got discharged on 08 oct 2017.Mri of the lumbar spine without contrast reveals extensive metal artifacts obscuring the l4-l5 vertebral bodies, right hemilaminectomy and medial facetectomy at l3.Scar tissue along the right lateral epidural space of l3-4, degenerative changes resulting in moderate right foraminal narrowing at l3-4.(b)(6) 2017: patient underwent ct scan and mri lumbar spine w/o contrast.Impressions: extensive metal artifacts obscuring the l4 and l5 vertebral bodies and partially the ventral aspect of the central canal.Right hemilaminectomy and medial facetectomy at l3 better seen.Scar tissue along the right lateral epidural space at l3-l4 is suspected.Degenerative changes resulting in moderate right foraminal narrowing at l3-l4 also noted.Patient underwent ct l-spine without contrast post processing.Impressions: no evidence of acute fracture or traumatic subluxation of the lumbar spine.Right l3 hemilaminectomy and medial facetectomy.Scar tissue along the right lateral epidural space at l3-l4 is questioned.Degenerative changes with likely moderate right foraminal narrowing at l3-l4 also noted.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.02 nov 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient underwent mr lumbar spine without contrast.Impressions: new 22 mm left erector spinal muscle mass at the l1 level is nonspecific.The signal characteristics with bright t1 signal raises possibilities that include hematoma, highly proteinaceous fluid collection and melanoma.Examination is non-diagnostic with respect to the lower lumbar spine due to ferromagnetic artifact.(b)(6) 2018: the patient underwent mr lumbar spine without and with contrast.Impressions: finding in the left dorsal musculature has diminished and is consistent with a hematoma or highly proteinaceous fluid collection.Artifacts at the lower lumbar levels obscure the anatomy.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient was admitted to the facility and got discharged on (b)(6) 2018.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient was admitted to the hospital (b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient underwent mr lumbar spine without contrast.Impressions: previously seen fluid collection in the left paraspinal musculature has resolved.Remaining ancillary findings mild degenerative changes, as described.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient was discharged from the hospital (b)(6) 2018: the patient came for follow up visit.

Manufacturer Narrative

Additional information: b5, g1, g2.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2010: the patient underwent x-rays of cervical spine (minimum 4 views).Results have not been provided.(b)(6) 2012: the patient underwent mri of foot.Results have not been provided.(b)(6) 2014: the patient underwent mri of right elbow without contrast.Results have not been provided.(b)(6) 2015: the patient underwent ultrasound of pelvic transabdominal and transvaginal.Results have not been provided.(b)(6) 2015: the patient underwent mri of lumbar spine and left shoulder without contrast.Results have not been provided.(b)(6) 2015: the patient underwent mri of head without contrast.Results have not been provided.(b)(6) 2018: the patient underwent mri brain without contrast.Results have not been provided.(b)(6) 2018: the patient underwent right upper extremity venous doppler.Results have not been provided.(b)(6) 2018: the patient underwent mri of lumbar spine with contrast and without contrast.Results have not been provided.(b)(6) 2020: the patient underwent mri of lumbar spine without contrast.Results have not been provided.

Manufacturer Narrative

Event Description

History/comorbidities: patient has had symptoms of depression since surgery; does have a history of bipolar disorder and has had cbt and emdr, mental status change, preventive health care, abuse, opioid, unspecified, headache, rebound, low back pain, phobias, other isolated or simple surgeries: botched surgery, lumbar discography at l3-4, l4-l5, l5-s1, minimally invasive lumbar microdisectomy at bilateral l3-4 and l4-5 family medical: patient works for the middlesex board of education as an administrative assistant for the past 19 years medication: xanax dilaudid (b)(6)2010: the patient underwent spine cervical min 4 views.Impressions: mild to moderate degenerative changes of the cervical spine.(b)(6)2014: patient came for follow up visit.Patient reported painful plantar fasciitis of the patient¿s right foot.The patient indicates that the plantar fascial pain has been occurring for the past 03 months and is now here for evaluation treatment of the left foot plantar fascia.(b)(6)2016: patient was admitted to hospital.(b)(6) 2016: patient was discharged from hospital.(b)(6)2017: the patient was admitted to hospital.(b)(6)2017: the patient was discharged from hospital.(b)(6)2017: the patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, psycho-education, relaxation/deep breathing, and structured problem solving (b)(6)2018: the patient came for follow up visit.Intervention used: psycho-education, structured problem solving, and supportive reflection (b)(6)2018: the patient was pre- operatively diagnosed with lumbalgia and lumbar spondylosis with radiculopathy.The patient underwent the following procedure- bilateral lumbar l5 dorsal primary ramus block and sacral s1, s2, s3 lateral branch nerve blocks with fluroscopy.As per op notes: the patient was placed in a prone position.Utilizing strict sterile technique, the skin was painted in an eccentric circular manner three times with duraprep and draped in a sterile fashion.The procedure tray was prepared and appropriate drugs were drawn up.Fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site of the l5 primary dorsal ramus and the s1, s2 and s3 posterior foramen.Local anesthetic wheals were raised using lidocaine 1 % 10 ml.A 22 gauge 3.5 inch spinal needle was advanced to the location of the l5 dorsal primary ramus at the junction of the superior articular process and sacral ala, as well as the lateral branch nerves at the lateral border of the posterior/dorsal sacral foramen utilizing intermittent fluoroscopy.Needle tip positioning was confirmed and adjusted via oblique, ap and lateral fluoroscopic imaging.Contrast dye was not required.Aspiration was negative.I administered a total amount of bupivacaine 0.25% preservative free 9 ml with triamcinolone preservative free 40 mg.This procedure yielded no wasted medication.The patient tolerated the procedure well and was transferred to the recovery room.The patient was provided with detailed post-procedure instructions and discharged in satisfactory condition.The patient was advised to schedule a follow-up appointment at the office in 2 weeks or earlier if necessary.(b)(6)2018: patient came for follow up visits.Patient said that she returned to work at her job and is working 20 hours per week.Says that she feel good about working and hopes that she can continue despite some ongoing discomfort from post surgery pain.Intervention used: exploration of relationship patterns, interactive feedback, psycho-education, and review of treatment plan/progress (b)(6)2018: the patient underwent x-ray l- spine.Impressions: new 22 mm left erector spinae muscle mass at the l1 level is nonspecific.The signal characteristics with bright t1 signal raises possibilities that include hematoma, highly proteinaceous fluid collection and melanoma.(b)(6)2018: patient came for follow up visit and said she was in severe pain in back and legs.She was trying not to take pain medication but needs to.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, and psycho-education (b)(6)2018: the patient was pre- operatively diagnosed with lumbalgia and lumbar spondylosis with radiculopathy and sacroiliac instability.The patient underwent the following procedure- bilateral lumbar l5 dorsal primary ramus block and sacral s1, s2, s3 lateral branch nerve blocks with fluroscopy.As per op notes: the patient was placed in a prone position.Utilizing strict sterile technique, the skin was painted in an eccentric circular manner three times with duraprep and draped in a sterile fashion.The procedure tray was prepared and appropriate drugs were drawn up.Fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site of the l5 primary dorsal ramus and the s1, s2 and s3 posterior foramen.Local anesthetic wheals were raised using lidocaine 1 % 10 ml.A 22 gauge 3.5 inch spinal needle was advanced to the location of the l5 dorsal primary ramus at the junction of the superior articular process and sacral ala, as well as the lateral branch nerves at the lateral border of the posterior/dorsal sacral foramen utilizing intermittent fluoroscopy.Needle tip positioning was confirmed and adjusted via oblique, ap and lateral fluoroscopic imaging.Contrast dye was not required.Aspiration was negative.I administered a total amount of bupivacaine 0.25% pres ervative free 11 ml with triamcinolone preservative free 40 mg.This procedure yielded no wasted medication.The patient tolerated the procedure well and was transferred to the recovery room.The patient was provided with detailed post-procedure instructions and discharged in satisfactory condition.The patient was advised to schedule a follow-up appointment at the office in 2 weeks or earlier if necessary.(b)(6)2018: patient came for follow up visit.Interventions used: interactive feedback and interpersonal resolutions.(b)(6)2018: patient came for follow up visit and said she wasn¿t able to perform at work due to physical pain.She talked about breathing and visualization techniques, and therapist demonstrated ways patient can learn to manage her discomfort.Interventions used: psycho-education, relaxation/deep breathing, and structured problem solving.(b)(6)2018: the patient was pre- operatively diagnosed with lumbalgia and lumbar spondylosis with radiculopathy.The patient underwent the following procedure- right lumbarbosacral radiofrequency ablation of l5 dorsal primary ramus block and sacral s1, s2, s3 lateral branch nerve blocks with fluroscopy.As per op notes: the patient was placed in a prone position.Utilizing strict sterile technique, the skin was painted in an eccentric circular manner three times with duraprep and draped in a sterile fashion.The procedure tray was prepared and appropriate drugs were drawn up.Fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site of the l5 primary dorsal ramus and the s1, s2 and s3 posterior foramen.Lidocaine 1 % 10 ml was injected in the skin and subcutaneous tissue, subsequently, 10 cm 18 gauge radiofrequency needles with a 10 mm active tip were advanced to the location of the l5 dorsal primary ramus at the junction of the superior articular process and sacral ala, as well as the lateral branch nerves at the lateral border of the posterior/dorsal sacral foramen utilizing intermittent fluoroscopy.Needle tip positioning was confirmed and adjusted via oblique, ap and lateral fluoroscopic imaging.Contrast dye was not required.At each level, right l5, s1, s2, and s3, i performed motor stimulation at 2hz up to 3 volts, which showed paraspinal muscle movement but no referral to the leg.I injected lidocaine 1 % 0.5 ml at each level prior to lesioning.Radiofrequency lesions were performed at the above stated levels at 42 degrees celsius for 90 seconds followed by a second lesioning at 80 degrees celsius for 90 seconds.Subsequently, i administered a total amount of bupivacaine 0.25% preservative free 11 ml with triamcinolone preservative free 40 mg.This procedure yielded no wasted medication.The patient tolerated the procedure well and was transferred to the recovery room.The patient was provided with detailed post-procedure instructions and discharged in satisfactory condition.The patient was advised to schedule a follow-up appointment at the office in 2 weeks or earlier if necessary.(b)(6)2018: patient came for follow up visit and said she is doing better and feels better with supervisor not present as she is not as stressful.Patient said she is trying to take decreased amounts of pain medication.Intervention used: psycho-education and supportive reflection (b)(6)2018: the patient was pre- operatively diagnosed with lumbalgia and lumbar radiculopathy.The patient underwent the following procedure- lumbar transforaminal epidural steroid injections at bilateral l4-l5 and bilateral l5-s1 with fluoroscopy.As per op notes: the patient was placed in a prone position.Utilizing strict sterile technique, the skin was painted in an eccentric circular manner three times with duraprep and draped in a sterile fashion.The procedure tray was prepared and appropriate drugs were drawn up.Fluoroscopic guidance was utilized in order to anatomically determine the proposed injection site at bilateral l4-l5 and l5-s1.The fluoroscope was lined up with the spine at the above stated levels.Local anesthetic wheals were raised using lidocaine 1 % 12 ml.A 20 gauge 6 inch spinal needle was advanced into the neural foramen via lateral oblique view under fluoroscopy at the above stated levels.Contrast dye was used.Omnipaque 240 mg/ml 4 ml was injected to confirm epidural spread under fluoroscopy a the above stated levels.Aspiration was negative for blood or csf.There was no paresthesias with needle placement.I then administered a total amount of triamcinolone preservative free 80 mg and preservative free saline 8 ml and marcaine 0.25% preservative free 2 ml.The patient tolerated the procedure well and was transferred to the recovery room.The patient was provided with detailed post-procedure instructions and discharged in satisfactory condition.The patient was advised to schedule a follow-up appointment at the office in 2 weeks or earlier if necessary.(b)(6)2018: patient came for follow up visit.Interventions used: psycho-education, structured problem solving, and supportive reflection.(b)(6)2018: patient came for follow up visit.Interventions used: exploration of relationship patterns, interactive feedback, and interpersonal resolutions.(b)(6)2018: patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, and supportive reflection (b)(6)2018: patient came for follow up visit.Interventions used: structured problem solving, and supportive reflection (b)(6)2018: the patient came for follow up visit.Interventions used: interactive feedback, and supportive reflection (b)(6)2018: patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, and role-play/behavioral rehearsal (b)(6)2019: patient came for follow up visit.Interventions used: psycho- education (b)(6)2019: patient came for follow up visit.Interventions used: psycho-education, and supportive reflection.(b)(6)2019: patient came for follow up visit.Interventions used: psycho-education, and supportive reflection.(b)(6)2019: patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, structured problem solving, and supportive reflection.(b)(6)2019: patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, and interactive feedback (b)(6)2019: patient came for follow up visit and talked about her therapies and how much better she¿s doing.Patient said that she occasionally has some panic attacks but able to use breathing to calm herself down.Intervention used: interactive feedback, interpersonal resolutions, psycho-education, and structured problem solving (b)(6)2019: patient came for follow up visit and talked about her depression and her therapy.Therapist did emdr with client to help her improve her self-esteem.Interventions used: exploration of emotions, exploration of relationship patterns (b)(6)2019: patient came for follow up visit.Interventions used: exploration of emotions, interpersonal resolutions, and structured problem solving (b)(6)2019: patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, psycho-education, and structured problem solving (b)(6)2019: patient came for follow up visit.Interventions used: interactive feedback and psycho-education (b)(6)2019: patient came for follow up visit.Interventions used: interpersonal resolutions, psycho-education, and structured problem solving (b)(6)2019: patient came for follow up visit.Interventions used: psycho-education, structured problem solving, and supportive reflection (b)(6)2019: patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, interpersonal resolutions, and supportive reflection (b)(6)2019: patient came for follow up visit.Patient was feeling better since getting an injection in her spine for pain.Patient said that she sees correlation between high levels of pain and lower self esteem.Interventions used: structured problem solving and supportive reflection (b)(6)2019: patient came for follow up visit and talked about her progress with treatment for cognitive issues following her surgery.Interventions used: guided imagery, interactive feedback, interpersonal resolutions, and psycho-education (b)(6)2019: patient came for follow up visit.Interventions used: exploration of emotion, exploration of relationship patterns, and interactive feedback (b)(6)2019: patient came for follow up visit and said she is experiencing some headache pain.Interventions used: interactive feedb ack, interpersonal resolutions, psycho-education, and supportive reflection (b)(6)2019: patient came for follow up visit and talked about her pain levels and sleeping issues.Patient said she is trying not to take her medication until night time.Patient said she is having issues sleeping during the night and talked her psychiatrist to see about medication to help her sleep.Interventions used: exploration of emotions, exploration of relationship patterns, interactive feedback, and psycho- education (b)(6)2019: patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, psycho-education, structured problem solving and supportive reflection (b)(6)2019: patient came for follow up visit.Interventions used: exploration of emotions, guided imagery, and interactive feedback (b)(6)2019: patient came for follow up visit.Interventions used: interactive feedback (b)(6)2019: patient came for follow up visit.Interventions used: exploration of coping patterns, exploration of emotions, interactive feedback, structured problem solving, and supportive reflection (b)(6)2020: patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, and interactive feedback (b)(6)2020: patient came for follow up visit.Interventions used: exploration of relationship patterns, guided imagery, psycho-education, and review of treatment plan/progress (b)(6)2020: patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, and interpersonal resolutions.(b)(6)2020: patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, and interpersonal resolutions.(b)(6)2020: patient came for follow up visit.Interventions used: exploration of emotions, exploration of relationship patterns, interactive feedback, and interpersonal resolutions (b)(6)2020: patient came for follow up visit.Interventions used: interactive feedback, interpersonal resolutions, psycho-education, structured problem solving, and supportive reflection (b)(6)2020: patient came for follow up visit.Interventions used: exploration of emotions and psycho-education (b)(6)2020: patient came for follow up visit.Interventions used: exploration of emotions, interactive feedback, interpersonal resolutions, and structured problem solving.

Event Description

Updated information received on 03-nov-2021: medications: depakote, protonix, cyclobenzaprine, cymbalta, lexapro.It was reported that on (b)(6) 2010: the patient came for a colonoscopy.Procedure: the patient was taken to the gi lab, connected to ekg monitoring, pulse oximetry and blood pressure monitoring.Next, she was given mac anesthesia by dr.(b)(6).Next, the colonoscope was introduced into the anus under direct vision, advanced through the rectum, sigmoid colon, descending colon, splenic flexure, transverse, hepatic flexure, ascending colon to the cecum.Once the cecum was reached, the ileocecal valve and the caput of the cecum were then identified.Upon withdrawing the scope, the mucosa was examined in a circumferential fashion, mucosa of the cecum appeared normal as did the ascending colon, transverse colon, descending colon.Sigmoid colon was found to contain scattered diverticula.The rectum appeared normal.The patient tolerated the procedure well and was taken to the recovery room in stable condition.(b)(6) 2012: the patient was admitted to the hospital for depression and suicidal thoughts.Hospital course: upon admission the patient was provided with a safe and supportive environment.She was encouraged to attend individual, group, and milieu therapy.She was placed on close observation.She was also started on ciwa with librium, also owa with suboxone.The patient was also started on prozac, risperdal, and depakote.The patient gradually responded to treatment.Her mood improved.Suicidal ideation subsided.There were no psychotic symptoms.There were no withdrawal symptoms.Family session held with the husband, seems very supportive.The patients case was discussed in the team round and it was suggested for partial hospital level of care.The patient agreed to go to gen psych for continuation of care.Discharge mental status: the patient appears her stated age, calm, cooperative, pleasant.Mood happy, bright affect.Denies psychotic symptoms like auditory or visual hallucinations.Denies any paranoid ideation.Denies any suicidal or homicidal ideation.Her cognitive function was intact.She was alert and oriented x3.Her judgment, insight, and impulse control were adequate.(b)(6) 2012: the patient was discharged.(b)(6) 2013: patient visited emergency room for chest pain.Patient had xr portable chest 1 view.Portable frontal radiograph reveals the lungs are clear.There is no pleural effusion.The cardiac silhouette is normal in size.(b)(6) 2015: the patient came for follow up visit.(b)(6) 2015: the patient came for follow up visit.(b)(6) 2015: patient had mr cervical spine without contrast.Impression bilateral foraminal narrowing at c3-c4.Bilateral foraminal narrowing at c4-c5 worse on the right.Bilateral foraminal narrowing at c5-c6 much worse on the right.Spondylitio changes c6-c7 with borderline spinal stenosis with effacement of ventral subarachnoid space.(b)(6) 2015: the patient came for follow up visit.(b)(6) 2015: the patient came for follow up visit.(b)(6) 2015: the patient came for follow up visit.(b)(6) 2015: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient visited emergency room for neck, back pain due to fall.Patient had the following radiographs.Ct cervical spine.Impression: no evidenec of acute fracture or dislocation.Ct head.Impression: : no acute intracranial pathology present.Xr right elbow.Impression: : normal x-rays of the right elbow.Xr left shoulder.Impression: left shoulder-within limits.Xr lumbosacral spine.Impression: mild degenerative changes.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2016: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: patient had xr chest.Impression: clear lungs.Patient had ct cta chest with contrast.Impression: moderate to large saddle embolus with extension of emboli to the subsegmental pulmonary arteries of the both lungs.Mild reflux of contrast to the ivc, however, no deviation of the intraventricular septum.Stranding and high-density fluid and retroperitoneal left abdomen associated with the iliopsoas muscle and extending to gerota's fascia.Correlate with recent surgery.Iliopsoas hematoma is suspected and should be considered.Patient had ct cta abdomen /pelvis wo/w contrast.Impression: extravasation of contrast adjacent to the stented portion of the proxi mal right common iliac artery, seen on the arterial phase images.This findinf is concerning for ongoing arterial bleeding.Doctor suspect the degree of bleeding has been limited by the presence of two overlapping right common iliac artery stents.Extensive thrombus in the inferior vena cava.Large retroperitoneal hematoma.(b)(6) 2017: the patient visited emergency room for chest pain and shortness of breath.(b)(6) 2017: the patient was admitted to hospital for pulmonary embolism/rehab.(b)(6) 2017: patient had a xr chest 2 view (ap and lat).Impression: modest left lower lobe retrocardiac consolidation and possible loculated.(b)(6) 2017: the patient was discharged from hospital.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2017: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.(b)(6) 2018: the patient came for follow up visit.Patient had lumbar transforaminal epidural steroid injections with fluoroscopy.(b)(6) 2018: patient had physical therapy from (b)(6) 2017 to (b)(6) 2018.(b)(6) 2018: the patient was admitted to hospital for cough.Patient had ct chest without iv contrast.Impression: mild bibasilar subsegmental atelectasis versus scarring.3mm left upper lobe nodule, unchanged, presumably benign.(b)(6) 2018: the patient was discharged from hospital.(b)(6) 2019: the patient came for follow up visit and had lumbar transforaminal epidural steroid injections with fluoroscopy.(b)(6) 2019: the patient came for follow up visit.(b)(6) 2019: the patient came for follow up visit.(b)(6) 2019: patient had emergency room visit for chest pain/hypotension.Patient had xr chest single view.Impression: postsurgical changes/catheters and support devices: status post median sternotomy.Monitoring leads overlie the chest.Lungs and pleural spaces: there is no pneumonia, edema or pneumothorax.Heart/mediastinum: within normal limits.Other no other significant findings.Summary: no active disease seen in the chest.(b)(6) 2020: patient came for follow up visit.(b)(6) 2020: the patient underwent mr lumbar spine w/o contrast.Impression: minimal grade i retrolisthesis unchanged at l3-4.Artifact related to prior iliac stenting causes field inhomogeneity limiting visibility of the l4 and 15 vertebral bodies and l4-5 disc space.13-4 very minimal disc bulge unchanged; mild right foraminal stenosis unchanged.(b)(6) 2020: patient had a trigger point injection and lumbar transforaminal epidural steroid injections with fluoroscopy.(b)(6) 2020: patient came for follow up visit.(b)(6) 2020: patient came for follow up visit.(b)(6) 2020: patient had lumbar transforaminal epidural injection at rightl3-l4and l4¿5 with fluoroscopy and epidurogram.

Manufacturer Narrative

Additional information added in b5.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Updated information received on 19-oct-2021: (b)(6) 2021: patient was admitted to hospital for right ankle fracture.Ct head w/o contrast impression: no evidence of acute intracranial hemorrhage, significant mass effect, or large acute territorial infraction.Ct chest/abd/pelvis w/o contrast endotracheal tube trends towards the proximal right maintem bronchus; approximately 2-3 cm retraction suggested.Scattered patchy opacities involving the lungs , compatible with mild multifocal pneumonitis.No evidence of acute traumatic injury involving the chest, abdomen, or pelvis.Cta head w/contrast no intracranial large vessel occlusion or high-grade stenosis.Cta neck w/contrast no significant stenosis of the cervical carotid or vertebral arteries.Areas of pneumonitis in the visualized lung parenchyma.Right ankle x-rays impression: right ankle: interval placement of an external fixator device.No significant change alignent of tibia and fibula fractures.(b)(6) 2021: patient was discharged from hospital.(b)(6) 2021: patient was admitted to hospital for displaced fracture.Patient had right ankle x-rays.Impression: right ankle interval orif of distal tibial and fibular fractures.Description.Of procedure: the patient was given a regional block in the preoperative holding area and brought to the operating room and placed in the supine position on the operating room table.After induction of general endotracheal anesthesia, a tourniquet was placed about the right thigh and a bump under the right buttock and the right lower extremity was prepped and draped in sterile fashion.A standard lateral approach to the fibula was utilized.This was done after inspecting the skin, which showed that it had recovered from the significant blisters that it had before.There was no undue swelling.Sharp and blunt dissection helped identify the superficial branch of the peroneal nerve, which was retracted out of harm's way.The fibula was exposed.It had started to heal in a slightly malunited position.Early fracture callus was taken down with rongeur and curette.Bone reduction clamps were used to reduce the long oblique and partially comminuted fracture.It was very well reduced in terms of length and alignment on the ap view.Two lag screws were placed using ao technique.One was a 3.5 screw anterior to posterior.The other was a 2.0 screw posterior to anterior.This was followed by placement of a one-third tubular plate in bridge plate fashion.This was contoured and then placed well over the lateral aspect of the fibula.A cortical screw was placed proximally, followed by unicortical cancellous screw distally.This resulted in a well reduced plate to bone that was properly positioned and that was confirmed on ap and lateral imaging.The plate was then sequentially filled with 3 additional bicortical screws proximally and one additional unicortical screws distally.Attention was then turned to the medial malleolus.A curvilinear incision was created over the medial malleolus.The saphenous vein was identified and protected.The medial malleolus had started to heal in a malunited position.The malunion was taken down.Callus was removed.The reduction was improved as confirmed on ap, lateral, and mortise imaging.Bone reduction clamp was placed followed-by placement of 2 parallel wires.These were free drilled and then two 45 mm partially threaded cancellous screws were placed.These had very good purchase.The wires were removed.Final images revealed a satisfactorily reduced ankle fracture.A stress view revealed no instability at the mortise.No syndesmotic screw was required.The wounds were copiously irrigated.And then closed with 0 vicryl followed by 2-0 vicryl followed by 3-0 nylon for the skin.A sterile dressing was applied followed by an ao splint.The patient was awakened and transferred to the pacu awake, stable.(b)(6) 2021: patient was discharged from hospital.(b)(6) 2021: patient was admitted to hospital.Hospital: course: patient was found hypotensive and brought in ed for further evaluation.On arrival her vss , she denies any chills and fever, no chest pain and no palpitations, denies any gi problems.B/w showed anemia and aki.Pt will be admitted for further work up and treatment as indicated.Patient was admitted, sepsis work up sent and renal artery doppler was done and antihypertensives held and she was started on ivf.Her bp improved significantly and her pain also remained stable and renal artery doppler showed significant left renal artery stenosis and her renal function improved to her baseline.Vascular surgery was consulted for left renal artery significant stenosis, recommended no work up or intervention is needed at this time as patient's bp is normal and to follow up with them in the clinic as outpatient for previous iliac artery stent follow up.Also (mn patient's husband who wants her to return to snf for continuation of rehab.So patient is transferred back to rehab as her bp and symptoms improved and stable and renal function improved.Patient is instructed to follow up with vascular surgery and her pcp and other consultants who she follows up with: facility provider can follow up and restart her antihypertensives which were help if bp is high and renal function remains stable.(b)(6) 2021: patient was discharged.

Manufacturer Narrative

Event Description

Updated information received on 21-jan-2021: 26-mar-2021: patient is readmitted for orthopedic surgery to right foot.(b)(6) 2021: patient had physical therapy from (b)(6) 2021.(b)(6) 2021: patient had occupational therapy from (b)(6) 2021.

Manufacturer Narrative

Event Description

Updated information received on 8-apr-2021: 13-may-2021: patient had sn observe/assess roc.On (b)(6) 2021: patient had physical therapy and ot evaluation (b)(6) 2021: patient had physical therapy revisit (b)(6) 2021: patient had ot revisit (b)(6) 2021: patient had lpn adct visit and physical therapy.(b)(6) 2021: patient had ot revisit and sn direct care visit (b)(6) 2021: patient has physical therapy revisit.On (b)(6) 2021: patient had ot revisit and discharge.On (b)(6) 2021: patient has sn direct care visit (b)(6) 2021: patient has physical therapy revisit.On (b)(6) 2021: patient had sn observe/assess roc.(b)(6) 2021: patient had ot evaluation.On (b)(6) 2021: patient has physical therapy revisit.On (b)(6) 2021: patient had sn direct care visit (b)(6) 2021: patient had ot revisit.(b)(6) 2021: patient has physical therapy revisit.On (b)(6) 2021: patient has physical therapy revisit.On (b)(6) 2021: patient has physical therapy, hha and sn direct care revisit.On (b)(6) 2021: patient has physical therapy revisit.On (b)(6) 2021: patient had hha visit.On (b)(6) 2021: patient has lpn adct visit.On (b)(6) 2021: patient was discharged from physical therapy.On (b)(6) 2021: patient had sn direct care visit (b)(6) 2021: patient had ot evaluation.On (b)(6) 2021: patient had sn direct care visit (b)(6) 2021: patient had hha visit.(b)(6) 2021: patient had lpn adct visit.On (b)(6) 2021: patient had msw evaluation.On (b)(6) 2021: patient was discharged from ot.On (b)(6) 2021: patient had hha visit.On (b)(6) 2021: patient had sn direct care visit and msw revisit.(b)(6) 2021: patient had lpn adct visit.On (b)(6) 2021: patient had sn direct care visit.On (b)(6) 2021: patient had msw revisit and sn direct care visit.On (b)(6) 2021: patient had sn direct care visit.On (b)(6) 2021: patient had msw revisit and was discharged from msw care.

Event Description

Updated information received on 04-jul-2022: history/comorbidities: excessive bleeding, high blood pressure, neurological disorder, emotional or psychiatric problem medication: viibryd, adderall xr, nabumetone, mupirocin topical 2% ointment (b)(6) 2020: pt underwent lumbar intra articular facet joint injection with fluoroscopy at bilateral l4-5,l5-s1 and bilateral lumbar and thoracic paraspinals.(b)(6) 2020: patient went for follow up.(b)(6) 2020: patient underwent lumbar medial branch nerve blocks with fluoroscopy at bilateral l3-5,s1 (b)(6) 2020: patient had lumbar transforaminal epidural injection at rightl3-l4and l4¿5with fluoroscopy and epidurogram (b)(6) 2021: patient had lumbar transforaminal epidural injection at rightl3-l4and l4¿5with fluoroscopy and epidurogram (b)(6) 2020: pt underwent for mr lumbar spine without contrast findings: significant ferromagnetic artifact completely obscures evaluation at l4 and l5 and partially obscures evaluation at l3 numbering: last fully formed disc space is designated l5-s1.Bones: normal vertebral body heights.Normal alignment.Marrow signal is within normal limits.Discs: normal disc height and signal intensity.Spinal cord: conus is normal in signal and terminates at the t12-l1 level.T12-l1: no disc bulge or herniation.No central or foraminal stenosis.L1-l2: no disc bulge or herniation.No central or foraminal stenosis.L2-l3: no disc bulge or herniation.No central or foraminal stenosis.L3-l4: possible right foraminal disc protrusion similar to prior.Evaluation of this level is limited by metallic susceptibility artifact.No central stenosis.L4-l5: nondiagnostic secondary to artifact.L5-s1: nondiagnostic secondary to artifact mri of the cervical spine was performed without intravenous gadolinium.Bones: normal vertebral body heights.There is metallic susceptibility artifact related to anterior fusion material from c3 3 through c5.The remainder of the marrow signal is unremarkable.Discs: disc desiccative changes and disc space narrowing at all the levels from c3-4 through c7-t1.Spinal cord: normal cord signal.Visualized posterior fossa is unremarkable.C2-c3: no disc bulge or herniation.No central or foraminal stenosis.C3-c4: bilateral uncovertebral joint hypertrophy contributes to bilateral neural foraminal stenosis.No central stenosis.C4-05: bilateral uncovertebral joint hypertrophy and congenitally short pedicles contributes to bilateral neural foraminal stenosis.No central stenosis.C5-c6: artifact related to hardware limits evaluation.There is suggestion of broad-based posterior osteophyte/ disc complex with right greater than left uncovertebral joint hypertrophy.Congenitally short pedicles.Moderate to severe bilateral neural foraminal stenosis.Mild central canal stenosis.C6-c7: broad-based posterior osteophyte/disc complex.Bilateral uncovertebral joint hypertrophy right greater than left.Congenitally short pedicles.Moderate central and moderate to severe bilateral neural foraminal stenosis.C7-t1: mild bilateral uncovertebral joint hypertrophy and disc osteophyte complex.Mild left greater than right facet hypertrophy.Mild left neural foramina! stenosis.No significant central or right neural foraminal stenosis.Other: no other significant findings.Impression: postsurgical changes status post anterior fusion c3-05.Metallic susceptibility artifact limits evaluation.Multilevel moderate to severe neural foraminal stenosis secondary to congenital stenosis and mild uncovertebral joint and facet hypertrophy.Findings are most pronounced at c6-7 where there is moderate central canal stenosis also.13-oct-2021: caudal epidural steroid injection under fluoroscopic guidance performed 02-nov-2021: patient went for full skin check.Full skin exam was performed.D/w pt in detail sun avoidance, sun protection, annual follow-up.Spf 35 or higher is recommended when in the sun as well as reapplication every hour.Must f/u prn new or changing moles.Start mupirocin topical ointment, 2%, 1 app, apply to excoriated skin, bid to excoriations, 30 days, 30 gram, refills 2.The importance of stopping picking has been emphasized.Warned pt that open skin can lead to skin infections such as cellulitis.Pt states she will try to refrain from picking skin, husband will help to remind patient.Discussion on the nature of actinic keratosis, clinical course, as well as possible treatment options was undertaken.As other procedures take precedence, we will postpone treatment until next visit.(b)(6) 2021: caudal epidural steroid injection performed (b)(6) 2021: pt went for actinic keratosis follow up.Cryotherapy actinic keratosis and cryotherapy benign lesion were performed (b)(6) 2021: pt underwent for ct lumbar spine without contrast.Findings: numbering: last fully formed disc space is designated l5-s1.Bones: mild lumbar levoscoliosis.Normal vertebral body heights.Minimal retrolisthesis of l3 and l4, unchanged from (b)(6) 2017.No acute fracture.Tiny l3 inferior endplate and l4 superior endplate schmorl's nodes.Spinal canal: t12-l1: no significant spinal canal stenosis or neuroforaminal stenosis.L1-l2: new tiny left-of-midline osteophyte without significant spinal canal stenosis or neuroforaminal stenosis, compared with (b)(6) 2017.L2-l3: no significant spinal canal stenosis or neuroforaminal stenosis.L3-l4: minimal retrolisthesis, mild bilateral facet hypertrophy, and ligamentum flavum thickening contributing to moderate right and mild left neuroforaminal stenosis without significant spinal canal stenosis.Prior right hemilaminotomy with significant interval regrowth of bone in surgical site.L4-l5: mild diffuse disk bulge slightly eccentric to the left, bilateral facet hypertrophy, and ligamentum flavum thickening contributing to mild rightneuroforaminal stenosis without significant spinal canal stenosis.Artifact from left iliolumbar embolization coil again partially limits evaluation of the left neuroforamen but with probable unchanged mild left neuroforaminal stenosis.L5-s1: bilateral facet hypertrophy and ligamentum flavum thickening contributing to mild bilateral neuroforaminal stenosis, unchanged.Other: right common iliac artery stent.Left iliolumbar embolization coil.Inferior vena cava filter.Also underwent for lumbosacral spine x-rays findings: soft tissues: postsurgical changes are seen.Ivc filter and vascular stent are seen.Vertebral segment numbering: within normal limits.Lowest well formed disk space considered l5-s1.Alignment: preserved.Bones/disk spaces: l3-4 and l4-5 posterior disk space narrowing is seen.Sclerotic degenerative changes of the pedicles noted l3-l5.(b)(6) 2021: caudal epidural steroid injection performed (b)(6) 2022: patient presented for follow up visit.The pain started 21 years ago after the patient was lifting boxes for her job and symptoms have been worsening.The pain is located in the low back area and radiates to the bilateral lower extremity(right>left).The pain is described as throbbing, stabbing, sharp, achy, pins and needles, tingling, numbness and is rated as 10 on a scale of 0-10.The pain is constant.The pain is exacerbated by prolonged standing and walking, bending over, twisting at the waist.The pain is mitigated by lying down, sitting with feet up.Patient denies bowel or bladder incontinence.Ct lumbar spine without contrast (b)(6) 2021: 1.L3-l4 prior right hemilaminotomy with significant interval regrowth of bone in surgical site.2.Additional overall mild multilevel lumbar spondylosis, grossly similar to 10/6/2017.Please see details above.X-ray lumbar spine (university radiology) (b)(6) 2021 multilevel degenerative changes.Mri lumbar spine without contrast (b)(6) 2021: nondiagnostic exam at l4-l5 secondary to metallic susceptibility artifact.Probable right l3-4 disc protrusion contributing to right neural foraminal stenosis, similar to previous exams but not well visualized secondary to artifact.Mri cervical spine without contrast (b)(6) 2021: postsurgical changes status post anterior fusion c-c5.Metallic susceptibility artifact limits evaluation.Multilevel moderate to severe neural foraminal stenosis secondary to congenital stenosis and mild uncovertebral joint and facet hypertrophy.Findings are most pronounced at c6-7 where there is moderate central canal stenosis also.01-mar-2022: patient went for follow up visit.Ct lumbar spine (b)(6) 2022 impression: 1.At l3-4 and l4-5 there are dallas grade 3 tears 2.At l5-s1 there is a dallas grade 2 tear.(b)(6) 2022: spinal cord stimulator trial 63685 performed (b)(6) 2022: patient went for follow up visit.(b)(6) 2022: spinal cord stimulater implant.(b)(6) 2022: patient went for follow up visit.(b)(6) 2022: patient went for incision check.(b)(6) 2022: patient went for follow up visit.S/p scs implant leads x 2 boston scientific with over 50% relief of pain; no post procedural complications.(b)(6) 2022: pt present for medication refill.(b)(6) 2022: patient went for follow up visit (b)(6) 2022: patient went for follow up visit.

Manufacturer Narrative

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Brand Name

METRX

Type of Device

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Manufacturer (Section D)

MEDTRONIC SOFAMOR DANEK USA, INC

4340 swinea rd

memphis TN 38118

Manufacturer (Section G)

MEDTRONIC SOFAMOR DANEK USA, INC

4340 swinea rd

memphis TN 38118

Manufacturer Contact

glen belmer

1800 pyramid place

memphis, TN 38132

6122713209

MDR Report Key

7693131

MDR Text Key

114139184

Report Number

1030489-2018-01002

Device Sequence Number

Product Code

LXH

UDI-Device Identifier

00885074451220

UDI-Public

00885074451220

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

EXEMPT

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer

Reporter Occupation

Attorney

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

07/17/2018

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Model Number

9569567

Device Catalogue Number

9569567

Device Lot Number

GZ15G028

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

07/04/2022

Was Device Evaluated by Manufacturer?

Date Device Manufactured

02/15/2016

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Unknown

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Other;

Patient Age

57 YR

Patient Sex

Female

Patient Weight

100 KG

Patient Ethnicity

Non Hispanic

Patient Race

White

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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