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

Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Nerve Damage (1979); Neuropathy (1983); Electric Shock (2554)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report an adverse event involving her medtronic spinal-cord stimulator.Patient stated from the day it was implanted on (b)(6) 2018, she experienced electrocuting from the device.Patient reprogrammed 5-6 times.Patient said she started having electrocuting all over her body, heart and across vagina.Patient stated that she dealt with this horrible feeling until finally in (b)(6) 2018 she had the device turned off.Patient said the next month, on (b)(6) 2018, the fda came out with an alert that these spinal-cord stimulator devices had not been researched enough and were potentially harmful to people.Patient stated she watched a news program by (b)(6) investigates regarding the issues and lack of research with these devices.Patient said when she finally went to have the device removed in (b)(6) of 2019, the doctor told her that her device malfunctioned.Patient now has permanent nerve damage down legs, arms, and butt.Patient said she still has a buzzing feeling in her butt, back, and left arm and permanent neuropathy which she was prescribed gabapentin for.Patient is very upset that fda continued people to use these devices after knowing harm potential.

• Brand Name: SPINAL-CORD STIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 10032341
• Report Number: MW5094407
• Device Sequence Number: 17752988
• Product Code: LGW
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 66 YR