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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESTOREULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION RESTOREULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37712
Device Problems Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Transient Ischemic Attack (2109); Burning Sensation (2146); Inadequate Pain Relief (2388); Numbness (2415); Dementia (4405); Implant Pain (4561)
Event Type  Injury  
Event Description

Pt with hx of chronic back pain states she was implanted with a medtronic restoreultra 37712 spinal cord stimulator. Pt reports that after a few weeks the stimulator stopped working. Pt states she went to her dr who informed her that the battery had flipped over and that the doctor had to mash over the implant site to reposition the battery. Pt states that the she felt severe pain but the battery was successfully repositioned and recharged. Pt states some time after doctor visit, that she developed pain at the implant site and that the battery would not hold a charge. Pt states that she was scheduled for a revision where the first device was explanted and she was implanted with a second restoreultra spinal cord stimulator. Pt states that the second device was defective as well due to an inability to charge the battery and also suffered from unresolved pain. Pt reports that since the explant of the 2nd device she has had continuous burning, stinging pain in her sides and lower back, neurological problems, intermittent bilateral foot numbness, difficulty laying on her sides, early onset dementia, brain lesions, and mini strokes. Pt states that she spoke with medtronic who alleges that the surgeon never sent back the defective devices so that they could investigate and submit report to fda. Pt reports that the surgeon alleges that a medtronic representative was in the room during explant of devices and that the representative took the devices. Pt states concern that medtronic has not reported this device to the fda and that she has had to deal with persisting health complications 10 years later as a result of these defective devices.

 
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Brand NameRESTOREULTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key12407408
MDR Text Key269762728
Report NumberMW5103657
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/31/2021
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number37712
Device LOT NumberNKF710062H
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/31/2021 Patient Sequence Number: 1
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