| Model Number 54840007535 |
| Device Problem
Break (1069)
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| Patient Problem
Numbness (2415)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from consumer via manufacturer representative regarding an event happened during post-op of the reported screw implanted during initial surgery.It was reported that, the screws were broken.Patient underwent initial surgery on (b)(6) 2020 with reported screw and has to receive revision surgery on (b)(6) 2021 due to breakage of screws.Patient reported that she has numbness in right leg.The broken screws were at the bottom.The broken screws were explanted and in the possession of patient.There were no further complications reported regarding the event.
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Event Description
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Information was received from consumer via manufacturer representative that the broken screws were at the bottom.The broken screws were explanted and in the possession of patient.The procedure/technique performed during revision was decompressive lumbar laminectomy l3-s1, removal of hardware, exploration of fusion, neurolysis, fusion, iliac crest marrow aspiration, allograft, autograft with instrumentation, bone morphogenetic protein.Additional information received on 2022-jul-12: patient demographics: gender- female; initials- (b)(6); dob/age-(b)(6) 1963; dob/age- 59 years; race- unknown; height-unknown; weight- unknown; ethnicity: no information.History/comorbidities: (pre-existing medical conditions, smoking status, prior surgeries) arthritis, chronic back pain, chronic neck pain, constipation, hypertension, numbness (right leg, left foot), postoperative nausea and vomiting, radiculopathy, spinal stenosis, lumbar region without neurogenic claudication, temporomandibular joint disorder (tmj) surgeries: bunionectomy, colonoscopy, excision, cyst (left inguinal area), hysterectomy, laminectomy, lumbar with decompression/fusion (revision decompressive lumbar laminectomy l3-s1, removal of hardware, exploration of fusion, neurolysis, fusion, iliac crest, marrow aspirate, allograft, autograft with instrumentation, bone morphogenetic protein) laminectomy ¿ lumbar, oophorectomy, tonsillectomy, tubal ligation.Allergies/intolerance: no known allergies.Family medical: no known problems.Social history: never smoker.Medication: amlodipine (norvasc) 5mgpo tab, docusate (colace) 100 mg po cap, estradiol (estrace) 1mg po tab, hydrochlorothiazide (hydrodiuril) 25 mg po tab, methocarbamol (robaxin) 750mg po tab, magnesium gluconate (magonate) 500 (27 mg) mg po tab, zinc 100 mg po tab, ascorbic acid (vit.C) 1000mg po tablet, diclofenac sodium (voltaren) 1% external gel, polyethylene glycol 3350 (miralax) 17g po pack, ondansetron (zofran) 4mg po tablet dispersible, oxycodone ¿ acetaminophen (percocet) 5-325 mg po tab, valacyclovir (valtrex) 1g po tab, gabapentin (neurontin) 300 mg po cap, naproxen (naprosyn) 500mg po tab, 2021-jun-14: patient had s/p lumbar fusion l3-s1 performed in (b)(6) 2020.Patient was doing very well post-operatively until several weeks ago.She developed acute pain in her right buttock and right hip with radiation into the right lower extremity.She states this did not give her any pain relief.Patient denies any bowel or bladder changes or saddle anesthesia.Radiographs: plain films ap lateral of the lumbar spine are performed to evaluate the fusion demonstrate instrumented fusion l3-s1.This was not seen on previous x-rays.Patient denies any falls or traumas.Impression: s/p lumbar fusion, lumbar ddd with radicular symptoms.On (b)(6) 2021: patient returned for re-evaluation.Patient had s/p decompression and fusion with instrumentation l3-s1.Patient had broken screws in sacrum, and she had pain in the area where the heads of the screws are likely rubbing.Radiographs: plain films are performed and reviewed to evaluate the fusion, demonstrate broken pedicle screw in the sacrum.Impression: s/p decompression and fusion l3-s1 for spondylolisthesis with spinal stenosis and broken hardware.On (b)(6) 2021: patient presented for six-week follow up.Patient had s/p revision lumbar fusion with hardware removal and removal of broken screws.She noticed improvement in terms of her symptoms.She was readmitted to the hospital shortly after surgery with epigastric pain and she was found to have abdominal abscess and she was on antibiotics.Patient had noticed improvements in terms of her back pain and radicular symptoms.Impression: s/p lumbar fusion.On (b)(6) 2021: patient consented to a telemedicine visit to monitor her recovery from her lumbar procedure performed.Patient is doing well.She denies any significant low back discomfort, radiculopathy or weakness, injuries or traumas since her last visit.Radiographs: plain films from (b)(6) 2021 performed outside of facility.There is evidence of laminectomy defect with expected bone consolidation.No significant breakdown in the surgical area or adjacent level changes.Impressions: s/p revision lumbar fusion, lumbar stenosis, lumbar radiculopathy.(b)(6) 2021: the patient was very pleasant female with broken hardware, the hardware was removed.She had in situ fusion.She reported, she is feeling better, but she still has persistent numbness and tingling.Radiographs: plain films were performed and reviewed to evaluate the fusion demonstrate in situ fusion.Impressions: s/p revision lumbar fusion, lumbar stenosis, lumbar radiculopathy.(b)(6) 2022: the patient appeared to office for evaluation of her right hip pain.She was last seen in the office on (b)(6) 2021.She reports that she has had right hip pain symptoms for the past several months.She reports that her pain is located on the right posterior sacroiliac joint region.She also reports pain along the right posterior buttock region.She describes that pain as aching and sharp.She reports that sometimes she feels that sensation of ¿opening up/something moving¿ of her right posterior hip/back region.She rates the severity of her pain as severe in the pain scale.She reports that rest helps alleviate her pain symptoms.She has a history of lumbar spine surgery with laminectomy and fusion on (b)(6) 202.She has recently been seen and evaluated in regard to her lumbar spine.She underwent ct lumbar myelogram testing.She underwent revision lumbar spine surgery in the interim since last office visit.She reports that she has been experiencing abdominal issues and underwent abdominal testing.The testing demonstrated a possible right labral tear.Imaging: x-rays of the ap pelvis and ap/lateral right hip were reviewed from (b)(6) 2021 at michigan orthopaedic and spine surgeons, to evaluate for pain.They demonstrate presence of mild right hip osteoarthritis changes with joint space narrowing and subchondral sclerosis.The is overall maintenance of the right hip joint space.There is noted to be orthopedic hardware noted in the visualized portion of the lumbar spine.Mr enterography performed on (b)(6) 2021 was reviewed.There is demonstration of a possible right hip labral tear.This is a non-arthrogram study.(b)(6) 2022: patient with s/p revision lumbar fusion with hardware removal, in situ fusion.She has noticed improvement in terms of her back pain and radicular symptoms.She was doing pt exercises with bands and thought the bands were providing too much resistance and her right knee has been bothering her since then.Radiographs: plain films ap and lateral of the lumbar spine performed and reviewed to evaluate the fusion demonstrate in situ fusion, bone grafts appear to be healing well and x-rays are stable compared to previous films.Impression: s/p revision lumbar fusion.(b)(6) 2022: patient last seen in the office in feb 2022.She is recovering for revision lumbar fusion performed in (b)(6) 2021.She is doing well.She has been involved with physiotherapy.Primarily doing manual therapy at this time.She continues to have a degree of chronic radiculopathy and numbness affecting the right lower extremity.She denies any weakness, falls or traumas, saddle area anesthesia.She has been slowly increasing her adls.Radiographs: plain films ap and lateral of the lumbar spine are performed today and personally reviewed secondary to postop status show in situ bony fusion l3-s1 good bone consolidation.Impression: s/p revision lumbar fusion.Physiotherapy performed on the patient on below dates: (b)(6) 2022 additional information received on 2022-jul-25: (b)(6) 2019: this is a new patient coming today for evaluation of the lumbar spine.She has had a chronic history of low back discomfort and radiculopathy affecting the right lower extremity.She has been through chiropractic care more recently.She has done pt and pain management in the past, however, not in 2019.She has no history of lumbar surgery.She notices the symptoms on a daily basis.She comes in today for a second opinion about a treatment plan.Radiographs: plain films ap, lateral, flexion and extension views of the lumbar spine are performed today and personally reviewed secondary to complaints of discomfort show malalignment l4-l5 with anterolisthesis.There is loss of disc space l5-l4.There is slight reduction with extension.Mri dated 8/8/19 from michigan resonance imaging ordered by dr.Lamacchia shows facet changes l5-s1 with mild changes of the disc without significant nerve compromise.At l4-l5, there is anterolisthesis with mild central canal stenosis, significant facet arthropathy, degenerative changes of the disc, and bilateral foraminal narrowing.There is increasing facet arthropathy l3-l4.2020-nov-02: patient visited for evaluation of lumbar spine.She is s/p lumbar fusion.She has noticed improvement in terms of back pain and radicular symptoms.She continues to have tightness in her low back and occasional radicular symptoms, numbness and tingling in bilateral lower extremities.She has a slightly difficulty in postoperative course.Patient has been following post-op restrictions.Radiographs: plain films ap, lateral, flexion and extension views of the lumbar spine performed today and personally reviewed to evaluate the fusion demonstrate lumbar fusion l1-s1.Hardware appears intact and bone graft appears to be consolidating.Impression: s/p lumbar fusion.(b)(6) 2020: patient returns to office, she is s/p decompressive lumbar laminectomy and fusion with instrumentation.She reports she is feeling significantly better.Radiographs: plain films are performed and reviewed to evaluate the fusion demonstration decompression and fusion with instrumentation doing well.Impressions: spinal stenosis, scoliosis s/p decompression, and fusion doing well.
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Manufacturer Narrative
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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.
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Event Description
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Additional information received on 2022-aug-17: 2020-aug-31: patient returns and said she has pain in her back with radiation in the buttock and leg.She reports the pain is severe and incapacitating to the point she is unable to function.On examination, she is a very pleasant female.Motor is 5/5 with the exception of ta and ehl which are 4/5.There is no clonus.Hoffmann is negative.Radiographs: review of radiographs including flexion.Extension and lateral views demonstrate spondylolisthesis with spinal stenosis at l3-l4,l4-l5 and l5-s1, anterolisthesis l4-l5 with 5mm of motion on flexion and extension.Impression: spinal stenosis, spondylolisthesis, and radiculopathy l3-s1.(b)(6) 2020: indications: kelly gritzinger is a very pleasant (b)(6) y a female who presented to the office with chief complaint of severe pain in the back with radiation to the buttock and leg.The patient reports the pain is severe and incapacitating to the point that the patient is unable to function all therapeutic options were explained to the patient in detail.They understanding there are no promises or guarantees as to the outcome of surgery.The patient had undergone a long course of conservative care including physical therapy, anti-inflammatories, pain clinic and epidural blocks and the patient elected to proceed.The risks of surgery, which include but are not limited to infection, failure of operation, need for future operations, possibility of injury to arteries, nerves, and veins, possibility of permanent numbness, tingling, weakness, loss of bowel and bladder function, the risk to adjacent levels, need for future surgery, possibility of pedicle screw fracture or displacement or loosening, possibility of failure of fusion, the fact that smoking adversely affects the fusion, the prolonged period of recovery including up to one year to eighteen months for bone healing and up to two years for nerve healing.The patient understands the risk of surgery, they understand there are no promises or guarantees and they elected to proceed informed consent is obtained.The pa was present for the entire procedure and participated is all aspects of the care.He functioned as a first assistant and helped facilitate the case.Procedure: after adequate general anesthesia was obtained the patient was placed prone on a jackson table, the back was prepped and draped in the usual stented fashion all bony prominences are adequately padded so there is no evidence of any areas where there is any pressure on the skin or bony prominences or nerves.A pause was then used for keystone and surgical consent verification.Once this was completed surgical prep was performed and the back prepped and draped in the usual sterile fashion.A single incision was made over the back dissection was carried to the level of the spinous process.Kocher was placed.Lateral x-ray was obtained for verification of the level.During this time, the paraspinous muscles were reflected off the tips of the spinous process and past the facet joints to the transverse processes.The facet joints and transverse processes are exposed, and isolated central decompressive laminectomy was then performed at l3-s1 using leksell rongeur and kerrison.The lateral recesses were completely decompressed.Neurolysis was performed using 4.0 curved and straight curettes.The patient was found to have severe central canal, lateral recess and foraminal stenosis.This was completely decompressed.Using curved and straight curettes as well as kerrison¿s, removal of ligamentum flavum, hypertrophic facet joints, and foraminotomies was then performed.Once again discectomies were performed at l3-4 and l4-5.Angled dural separators had been passed to make sure that all nerve roots were free.Once it had been ascertained that there was no evidence of any residual central canal, lateral recess or foraminal stenosis attention was then turned to placement of the pedicle screws.The pedicle screw starting hole position was identified followed by placement of pedicle finder.Once pedicle verified, the top was then used with placement of a ball probe with verification and visualization of pedicles to ensure there is no breach of the pedicle or nerve root contact once this was performed, the screws was then measure and placed.6.5 x 40 screws were used at l3-l5.7 5x 35 mm screws were used in s1 bilaterally.Following this, a rod was then placed into the wound, distraction was carried out when necessary.Bone marrow aspiration was then performed using the trocar and the iliac crest 60 cc of bone marrow was then mixed with allo-autograft and placed over decorticated transverse processes.The construct was tightened into position and an x-ray was obtained for verification and position of the hardware.The neural foramina were once again palpated for a final time to ensure there was no evidence of any residual nerve compression.The fascia was then reapproximated with #1 vicryl over a medium hemovac drain, subcutaneous tissue was closed with 2-0, the skin was closed with 4-0 and steri-strips were applied.The patient tolerated the procedure well and was taken to the recovery room in satisfactory condition.There were no complications.Specimen(s) removed: scar, arthritis, disc, spur.Operation: decompressive lumbar laminectomy l3-s1 with foraminotomies with discectomy with posterolateral fusion l3-51 with bone marrow aspiration with allo/autograft posterolateral fusion l3-s1 with segmental pedicle screw fixation l3-s1.(b)(6) 2020: the patient returns to office and she had s/p decompressive lumbar laminectomy and fusion with instrumentation.She reports she is feeling significantly better.She went to florida for six weeks and reports it has been great.Radiographs: plain films are performed today and reviewed to evaluate the fusion demonstrate decompression and fusion with instrumentation doing well.Impression: spinal stenosis, scoliosis s/p decompression, and fusion doing well.(b)(6) 2021: the patient returns for reevaluation.She is s/p decompression and fusion with instrumentation l3-s1.Unfortunately, she had broken screws un the sacrum.She has pain in the area where the heads of the screws are likely rubbing.Radiographs: plain films are performed today and reviewed to evaluate the fusion demonstrate broken pedicle screw in the sacrum.Impression: s/p decompression and fusion l3-s1 for spondylolisthesis with spinal stenosis and broken hardware.(b)(6) 2021: indications: patient presented to the office with chief complaint of severe pain in the back with radiation to the buttock and leg.The patient reports the pain is severe and incapacitating to the point that the patient is unable to function.All therapeutic options were explained to the patient in detail.They understanding there are no promises or guarantees as to the outcome of surgery.The patient had undergone a long course of conservative care including physical therapy, anti-inflammatories, pain clinic and epidural blocks and the patient elected to proceed.The risks of surgery, which include but are not limited to infection, failure of operation, need for future operations, possibility of injury to arteries, nerves, and veins, possibility of permanent numbness, tingling, weakness, loss of bowel and bladder function, the risk to adjacent levels, need for future surgery, possibility of pedicle screw fracture or displacement or loosening, possibility of failure of fusion, the fact that smoking adversely affects the fusion, the prolonged period of recovery including up to one year to eighteen months for bone healing and up to two years for nerve healing.The patient understands the risk of surgery, they understand there are no promises or guarantees and they elected to proceed.Informed consent is obtained.The pa was present for the entire procedure and participated is all aspects of the care.He functioned as a first assistant and helped facilitate the case.Procedure: after adequate general anesthesia was obtained the patient was placed prone on a jackson table, the back was prepped and draped in the usual sterile fashion.All bony prominences are adequately padded so there is no evidence of any areas where there is any pressure on the skin or bony prominences or nerves.A pause was then used for keystone and surgical consent verification.Once this was completed surgical prep was performed and the back prepped and draped in the usual sterile fashion.A single incision was made over the back.Dissection was carried to the level of the spinous process.Kocher was placed.Lateral x-ray was obtained for verification of the level.During this time, the paraspinous muscles were reflected off the tips of the spinous process and past the facet joints to the transverse processes.The facet joints and transverse processes are exposed and isolated.The previous hardware was identified and removed, and the fusion was explored.The sacral screws were broken bilaterally, and the broken screw removal set was used and the screws were removed.Revision decompressive laminectomy was then performed at l2-s1 using leksell rongeur and kerrison.The lateral recesses were completely decompressed.Neurolysis was performed using 4.0 curved and straight curettes.The patient was found to have severe central canal, lateral recess and foraminal stenosis.This was completely decompressed.Using curved and straight curettes as well as kerrison¿s, removal of ligamentum flavum, hypertrophic facet joints, and foraminotomies was then performed.Discectomy was then performed using a 15-scalpel blade and pitutaries at l5-s1.Angled dural separators were then passed x3 sequentially into each neuro-foramina to make sure that all nerve roots wore free.Once it had been ascertained that there was no evidence of any residual central canal, lateral recess or foraminal stenosis attention was then turned to placement of the bmp.Bone marrow aspiration was then performed using the trocar and the iliac crest 60 cc of bone marrow was then mixed with allo-autograft and placed over decorticated transverse processes.The neural foramina were once again palpated for a final time to ensure there was no evidence of any residual nerve compression.The fascia was then reapproximated with #1 vicryl over a medium hemovac drain, subcutaneous tissue was closed with 2-0, the skin was closed with 4-0 and steri-strips were applied.The patient tolerated the procedure well and was taken to the recovery room in satisfactory condition.There were no complications.Specimen(s) removed: scar, broken hardware, arthritis, disc, spur (b)(6) 2021: patient is a very pleasant female with broken hardware.The broken hardware has been removed.She had a in situ fusion.She reports that she is feeling better but still has patient numbness and tingling.Radiographs: plain films are performed today and reviewed to evaluate the fusion demonstrate in site fusion.Impressions: s/p removal of hardware, in situ fusion, broken hardware.
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Manufacturer Narrative
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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.
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Event Description
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Additional information received on (b)(6)2022: (b)(6)2020-: it was reported that patient has history of hypertension and taking medications.Patient also state that she is scheduled in september for back surgery.Medical history, surgical history, family and social history and current medication/allergy list are reviewed and updated.She has been on her current medications for blood pressure for several years and is not having any issues.Her last blood work was done in february.She had a colonoscopy in 2010 and was told she needed to repeal in 5 years.Patient is here to establish.She has a history of hypertension and lumbar disc disease.She has been working with dr.Easton's office and is in the process of scheduling surgery.Patient tells me she has numbness and tingling in her feet and the bottom of her feet feel funny.She is able to tolerate the pain in her lower spine.1.Hypertension: bp is controlled on current medications.No changes at this time.Patient is advised to limit salt intake, continue with regular exercise and take asa 81 mg daily.Lab work and prescriptions refilled as necessary.Follow up as instructed.Medication list is reviewed with patient, and they are instructed to continue as follows: no changes at this time.Blood work and mri are discussed with the patient and all of patient¿s questions and concerns are answered to their satisfaction.2.Lumbar radiculopathy: mri of spine reviewed patient is in the process of scheduling surgery with dr.Easton.She will schedule pre-op appointment afterward.2020-sept-09: here for pre-surgical clearance.Pt notes here for surgical clearance pt states feeling well and she has scheduled an appointment with neurologist for second opinion.Ekg was performed.Procedure: lumbar fusion: when: 09/23/2020 where: beumont troy hospital, who: dr.Easton.Patient states she is doing well at this time and is ready for surgery she is on amlodipine 5 mg daily for blood pressure control.Denies chest pain shortness of breath palpitations and syncope.1.Other specified pre-operative examination: ekg sr normal axis otherwise normal.Patient is medically cleared at this time with low risk, lab work is ok.2.Lumbar radiculopathy: patient is scheduled for decompressive lumbar tami 14-6 possible fusion l3, with allograft and instrumentation blood work is discussed with the patient and all of patient¿s questions and concerns are answered to their satisfaction.(b)(6) 2021: here to follow up on blood pressure.Has been taking medications on a regular basis and checking readings as an outpatient.No problems with medications.Denies headache, vision problems, chest pain, sob, or change in bowels or bladder function.She is also having difficulty with decreased hearing.She was evaluated while in florida, mri was negative for acoustic neuroma.She would like to be reevaluated here in michigan.Patient denies any chest pain, shortness of breath, or dyspnea on exertion, no palpitations, presyncope, or syncope.No leg swelling or pain that is new for them.Patient denies any change in bowel or bladder function no melena, hematochezia, or dysuria, frequency of urgency, patient denies dyspepsia or abdominal pain.Well-nourished and well developed in no acute distress.Heent: affect is normal and appropriate.Mucosa pink and moist.Neck: carotids normal no bruits, thyroid normal.Lungs: cta.Heart: rrr s1s2 normal without murmur.Ext: no cyanosis or edema, pulses intact bilaterally.Galt is wnl 2021-may-05: here for complete physical.Here today for cpe.Patient is s/p lumbar fusion.Patient states she is doing well and making progress.She was started on blood pressure medication at last visit.She is not having any issues with the medication and her blood pressure is much better.She states she snores at night and is troubled with daytime fatigue.Gen: patient denies any recent fever, chills, headache, change in weight without trying.Heent: no vision or hearing problems.Cv: no cp, sob, doe, pnd, orthopnea, or peripheral edema.Heme/lymph: they note no lumps or swollen glands.Skin: no new rashes, changing moles, gi: no abdominal pain nausea vomiting or diarrhea, no change in bowel, no melena or brbpr gu: no change in bladder function, no urinary frequency no urgency no incontinence no hematuria.Neuro: no changes in memory, non-focal exam psych: mood has been good and overall doing well.2021-may-25: possible uti.Patient denies any fever, chills, or malaise.Feeling generally well.Patient denies any chest pain, shortness of breath, or dyspnea on exertion.No palpitations, presyncope, or syncope.No leg swelling or pain that is new for them.Patient denies any change in bowel or bladder function.No melena, hematochezia, or dysuria, frequency.Or urgency.Patient denies dyspepsia or abdominal pain hypertension.Pt.States she is having uti symptoms since last night when got back from her vacation.Pl.States frequent urination and a lot of pressure, cannot empty her bladder and had chills this morning, denies fever, side or back pain.1.Routine general medical examination at a health care facility: discussed issues including seatbelts, smoke detectors, mole warning signs, sunscreen use, and tick/mosquito avoidance.Discussed colonoscopy screening to detect cancer and gave gi referral name and number.Check labs/ekg.2.Lumbar radiculopathy: s/p fusion, patient is making good progress post-op.Follow up with ortho spine as instructed.2021-july-14: patient had ct myelogram on 8/25/2021, here to discuss results.Patient would like to know if she should get the covid shot before surgery, myelogram shows fractured bilateral pedicular screws at s1 as well as other degenerative changes.Patient scheduled for surgery august 3rd.She is feeling well without complaints.Gen: patient denies any recent fever, chills, headache, change in weight without trying.Heent: no vision or hearing problems.Cv: no cp, sob, doe, pnd, orthopnea, or peripheral edema.Heme/lymph: they note no lumps or swollen glands.Skin: no new rashes, changing moles, gi: no abdominal pain nausea vomiting or diarrhea, no change in bowel, no melena or brbpr gu: no change in bladder function, no urinary frequency no urgency no incontinence no hematuria.Neuro: no changes in memory, non-focal exam psych: mood has been good and overall doing well.1.Other specified pre-operative examination: ekg sr normal axis otherwise normal.Patient is medically cleared at this time with low risk.2.Hypertension: bp controlled on amlodipine 5 mg daily.Limit salt intake.No change in medication.Ekg: sr normal axis o/w normal patient is medically cleared at this time with low risk.She is advised to stop all asa, nsaid's, vitamins and supplements 5-7 days prior to surgery.Continue blood pressure medication per anesthesia instructions.2021-august-11: patient is here for surgical follow-up.Patient states she still has numbness in the right leg and foot.Otherwise, she states she is fine overall.Patient states she is doing well post-op.Her pain has been under control without the use of pain medication.She is having numbness and tingling in the right leg which has been difficult to tolerate.She is following her post-operative instructions in terms of activity and wearing of the brace.She is due to see dr.Easton on august 30th.1.History of decompressive lumbar laminectomy: patient is doing well post op.Some decompressive nerve discomfort.Trial of gabapentin 300 mg qhs.Risks benefits and side effects discussed with patient.Continue activities as instructed.Follow up with dr.Easton august 30.2021-august-30: patient is here for follow-up on htn, and medications.Patient here to discuss test results.Patient had mri enterography and is here to go over results.She started augmentin 500 mg bid this weekend and is doing ok with the medication.She denies fever chills nausea or vomiting.She states her abdominal pain is under control.She has noted a decrease in her appetite but is able to eat.She saw the ortho spine pa this am and has been given the ok to travel to florida.Patient is set to go to florida on the 1st.Well-nourished and well developed in no acute distress.Heent: affect is normal and appropriate.Mucosa pink and mold carotids normal no bruits, thyroid normal.Lungs cta.Heart rrr s1s2 normal without murmur ext: no cyanosis or edema, pulses intact bilaterally.Gait is wnl 1.History of decompressive lumbar laminectomy: patient is doing well and has received the ok to travel continue with ortho spine in structions.2022-january-06: patient is here for follow-up on htn and medications, patient here to discuss test results.Here to follow up on blood pressure.Has been checking readings as an outpatient denies headache, vision problems, chest pain, sob, or change in bowels or bladder function.Patient is also here to go over mri of abdomen.Her abdominal pain has resolved, and the mri shows resolution as well.She underwent egd with dr.Brawl which was ok.She will continue protonix she also completed sleep studies and was started on cpap.Well-nourished and well developed in no acute distress.Heent: affect is normal and appropriate.Mucosa pink and moist.Neck: carotids normal no bruits, thyroid normal.Lungs: cta.Heart: rrr s1s2 normal without murmur.Ext: no cyanosis or edema, pulses intact bilaterally gait is wnl 2022-april-07: patient here for follow-up on htn, gerd, and medications patient is here for follow up on hypertension, abdominal abscess and ortho issues.She has been to see the ortho' for pain in the knee and hip.They injected the knee and recommended conservative management for the hip.She states both are better.She has also been back to ortho spine for follow up from surgery and is doing well in that regard.She is also here for follow up on blood pressure.She is on amlodipine 5 mg daily and hctz 25 mg daily she is not having any problems with the medication and her blood pressure has been ok.She denies chest pain shortness of breath pal pitations or syncope.No edema.She has had complete resolution of the abdominal pain she has been back to gl and had egd recently pathology from biopsy was negative repeat imaging of the abdomen shows resolution of what was thought to be an abscess.She tells me her gerd is under control at this time.She is also here for follow up on blood pressure.She is on amlodipine 5 mg daily and hctz 25 mg daily she is not having any problems with the medication and her blood pressure has been ok.She denies chest pain shortness of breath palpitations or syncope.No edema.No other issues at this time.Well-nourished and well developed in no acute distress.Heent: affect is normal and appropriate.Mucosa pink and moist.Neck: carotids normal no bruits, thyroid normal lungs: cta.Heart rrr s1s2 normal without murmur.Ext: no cyanosis or edema, pulses intact bilaterally.Gait is wnl 2022-october-06: patient states overall she is good.She is having trouble with right knee pain.She saw ortho and they look x-ray.They told her it is coming from the spine; knee joint is ok.Gen: patient denies any recent fever, chills, headache, change in weight without trying, heent: no vision or hearing problems.Cv: no cp, sob, doe, pnd, orthopnea, or peripheral edema.Heme/lymph: they note no lumps or swollen glands.Skin: no new rashes, changing moles, gi: no abdominal pain nausea vomiting or diarrhea, no change in bowel, no melena or brbpr gu: no change in bladder function, no urinary frequency no urgency no incontinence no hematuria.Neuro: no changes in memory, non-focal exam.Psych: mood has been good and overall doing well.1.History of decompressive lumbar laminectomy; doing better, still having some pain with movements especially into the right leg.Recent mri discussed with patient.She will follow up with ortho spine.Scan results: 29-jul-2021: lumbosacral view ¿ comparison: ct of lumbar spine from 25/jun/2021.Impression: 1.Lateral intraoperative film demonstrates laminectomy changes in the lower lumbar spine and interval removal of the previously seen fusion hardware from l3 through s1.Minimal anterolisthesis of l4 on l5.Refer to the operative report for further real-time findings.02-sept-2022: mri lumbosacral spine with and without contrast.9/5/2022 there graft history: low back pain, right sided, sciatica multiplanar, multi sequential magnetic resonance imaging of the lumbosacral spine was obtained both before and after the uneventful administration of 10 cc mv contrast.There are no similar examinations for comparison at this institution.Postoperative findings seen within the mid and lower lumbar spine, with posterior decompression at each of these levels.There is straightening of the posterior soft tissues and there appears to be a small contained simple appearing fluid collection measuring 1.4 x 22 x 5.2 cm in ap, transverse and cranial caudal dimensions.There is no evidence of unexpected, abnormal enhancement.These findings are probably related to seroma.The conus terminates at l1, demonstrates normal signal morphology and the nerve roots are grossly unremarkable.There is no evidence of abnormal enhancement of the conus or the nerve roots.There is some anterolisthesis of l3 upon l4 and l4 upon l5 and there is slight levo scoliosis of the lower lumbar spine.There is no compression fracture seen.There is no traumatic malalignment.Some heterogeneity of the marrow spaces consistent with fatty marrow conversion.There is no infiltrative signal abnormality to suggest a marrow placing process.No pathologic edema on the fluid sensitive sequence.There is scattered disc space height loss at multiple levels without evidence of abnormal enhancement.At t11-t12, t12-l1, l1-l2, normal.No significant spinal canal stenosis or neural foraminal narrowing.At l2-l3, mild facet changes without significant spinal canal stenosis or neural foraminal narrowing.At l3-l4.Unroofing of the disc with posterior decompression.The thecal sac is patent and the neural foramina are slightly narrowed on the left and patent on the right.At l4-l5, unroofing of the disc and there has been posterior decompression with a patent thecal sac overall.Facet changes are seen bilaterally and there is minimal right-sided neural foraminal narrowing.Left neural foramen is patent.At l5-s1, facet changes bilaterally and posterior decompression.A disc spur herniation without significant spinal canal stenosis and there is minimal left-sided neural foraminal narrowing.Right neural foramen is patent.Limited assessment of the retroperitoneal soft tissues and appears final soft tissues are within normal limits.
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Manufacturer Narrative
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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.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.
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Manufacturer Narrative
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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.
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