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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problems Arthritis (1723); Irritation (1941); Nerve Damage (1979); Pain (1994); Respiratory Distress (2045); Swelling (2091); Therapeutic Effects, Unexpected (2099); Weakness (2145); Cramp(s) (2193); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Disc Impingement (2655)
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the consumer reported that her implant surgery was supposed to be the same day surgery but something went wrong. The patient was in excessive pain and screamed for 12 hours in pain and her legs ¿explode enormous¿. The patient was on a ventilator and stayed in the hospital intensive care for a week. The patient stated the healthcare professional made her worse than before and she ended up almost dying. The patient explained that her trial was wonderful and the permanent implant had not helped her pain, she was still on pain meds. The patient mentioned she was sent home not knowing how to use the device because she was so high on pain meds and no one had ever shown her the proper way of using the device. A manufacturer representative set it up for her once and it worked wonderfully. The indications for use were non-malignant pain and complex regional pain syndrome type i.
 
Manufacturer Narrative
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
Additional information was received from a healthcare provider (hcp). The hcp reported that they received a voicemail regarding the event requesting medical records. The hcp reported that the event occurred in (b)(6) 2016 and the patient was fine currently. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the health care provider (hcp) on 2017-dec-15 reporting that the patient was admitted on (b)(6)2016 for significant right lower extremity pain (sharp stabbing pain from knee to foot which was noted to be a likely exacerbation of their crps) following the placement of the scs. The patient had told the hcp that this pain was much worse than the pain from initial crps diagnosis where the patient would get spasms. X-rays were taken but came back negative with the following results: (chest) et tube in good position above carina. Right basilar fibroatelectasis. Suboptimal ventilatory effort. Medical appliance overlies right upper quadrant and lower thoracic spine. Heart and central vessels normal. Old rib fractures. (tibia/fibula) negative tibia and fibula. No fracture. (foot) negative foot. No fracture or dislocation. Mri findings were recorded as the following: 5 lumbar vertebrae vertebral bodies assumed. Normal distal cord with conus extending to mid ll. Postoperative changes placement of neurostimulator entering spinal canal at tl2-ll posteriorly with tip at tl0-11 level. Left lumbar scoliosis. The mri conclusions were noted as the following: postoperative changes placement of neurostimulator entering spinal canal at tl2-ll posteriorly with tip at tl0-11 level. Left lumbar scoliosis. Mildly increased t2 signal pedicles of l4 and ls on the left. This is likely due to increased stress and reactive edema. 3 mm anterior subluxation l4 on ls. Moderate to marked left foraminal narrowing at ls-sl. Mild right foraminal narrowing at l4-5. No significant canal narrowing at any level. Pain control was attempted with valium, fentanyl, neurontin, decadron, epidural straight ejection, lumbar sympathetic block to no avail. The patient was then given iv dilaudid and then transferred to the icu for ketamine and dilaudid. Later that evening the patient developed respiratory depression which required intubation for airway control. It was reported that the acute respiratory failure due to sedation medications. The intake/output summary from (b)(6)2016- to (b)(6)2016 was reported to be intake 230 ml output 200 ml net 30 ml. The patient was extubated on (b)(6)2016 and was again placed on ketamine infusion and lumbar sympathetic block. It was reported that the patient¿s pain improves to the point that they wanted to go home and they were discharged on (b)(6)2016. A prescription for percocet was provided. A follow-up appointment with the hcp for (b)(6)2016. No changes were made to existing management of the patient's other medical conditions as they were deemed at baseline. Recent labs done on (b)(6)2016 were noted to have the following values: sodium 143, potassium 3. 5 creatinine. 69, glucose 81, and calcium 7. 9 l. Medications at the time of discharge were reported to be gabapentin 300 mg capsule 3 capsules 3 times a day, clonazepam 0. 5 mg tablet once a day, alendronate 70 mg tablet once a week, ascorbic acid (vitamin c) 500 mg tablet 2 a day, aspirine, calcium, clonidine patch 0. 1 mg/24 hr 0. 1 mg/24 hr, ventolin hfa 90 mcg/actuation if needed, and oxycodone-acetaminophen (5-325 mg. The patient had a history of complex regional pain syndrome type i in both lower extremities (b)(6)2012 due to a work related injury (b)(6)2013, rsd lower limb (b)(6)2012, knee pain (b)(6)2011, right foot pain (b)(6)2011, metatarsalgia right foot (b)(6)2011, a stress fracture of right femur lateral condyle (b)(6)2011, breast surgery in 1985 and 1986, hernia repair, in 1993 and 1980, and a tubal ligation in 1991. The patient was a current smoker with a history of smoking 0. 15 packs a day for 35 years. The hcp reported that t11-12 seems to be fine. No neurologic compression, no sign of hematoma, etc. L4-5 spondylolisthesis with mild to moderate lumbar stenosis. While this might cause pain, it's not likely to cause the severity of pain that we are seeing. In other words, there doesn't appear to be a clear anatomic cause for the patient¿s pain. It might be possible that they had some mild l5 radiculopathy secondary to the l4-5 spondylolisthesis, but this in combination with crps pain is causing severe pain. The hcp might consider l4-5 esi or right l5 transforaminal esi or possibly right l4-5 decompression. A manufacturer representative met with the patient to adjust scs settings around 1030. The hcp discussed the possibility of emg with ncs to the right le to r/o peroneal nerve injury and possible right l5 selective esi. The hcp reported that per the patient when left lower extremity compression device inflates this worsens the right lower extremity pain. A manufacturer representative met with the patient to adjust scs settings around 1030. When the hcp met the patient at around 1315 on (b)(6)2016 the patient reported better pain control and rare muscle spasm. The patient felt their pain was much improved and mostly tolerable. They still have weakness in their right foot. Toes/foot are swollen and the patient was unable to walk. The patient was sleeping only 2-3 hours at a times, did not have an appetite was somewhat nauseated, and could not remember anything until saturday afternoon ((b)(6)2016).
 
Manufacturer Narrative
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
Information was received from a manufacturer representative and healthcare provider regarding a patient who was implanted with a ne urostimulator. It was reported that the patient was implanted that morning with a 565 lead and immediately in post-op was having right foot and calf pain. The manufacturer representative thought it looked like cramping. The patient at complex regional pain syndrome (crps) and was implanted for bilateral lower extremity pain form the knee down so the lead went in about t11/t12. It was reported that this placement did not correspond with the dermatome for the feet. It was reported that they were waiting to send the patient for an mri to check for a possible disc herniation. This was reported to be sudden on (b)(6) 2016. Additional information was received from a health care professional (hcp) at the pain clinic reporting that the patient had immediate severe right leg pain post-operatively. The caller stated that they talked to the mri and faxed guidelines to them which indicated that the patient was okay to be scanned; however, the mri wanted verbal confirmation. The caller asked technical services to call mri directly. Technical services contacted the technician in the mri department and indicated that all the information was received and they were good to go and did not need anything further. The technician reported that they had the contact information they needed in case they had another question.
 
Manufacturer Narrative
(b)(4). No longer applicable to event, per additional information received. 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
Additional information received from the manufacturing representative indicated that the patient¿s mri results were negative with the exception of some arthritis at l4 and l5. There was no disc herniation. The manufacturing representative heard discussion of possible severe flare of crps. It was noted that the patient is finally resting easier and has a pca for pain that they are using much less. The patient remains hospitalized for further observation at this time.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6181498
MDR Text Key101742674
Report Number3004209178-2016-26632
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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