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

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.

• Brand Name: RESTOREULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 12407408
• MDR Text Key: 269762728
• Report Number: MW5103657
• Device Sequence Number: 2
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37712
• Device Lot Number: NKF720222H
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability