MAUDE Adverse Event Report: Medtronic Inc. SPINAL NERVE STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Electric Shock (2554)

Event Date 07/01/2018

Event Type  Injury  

Event Description

Have a medtronic nerve stimulator in my back.Second one that doesn't work and hasn't.Will get all of a sudden feel a shock like feeling around the battery pack and want to drop to the floor or i am unable to move.Have been trying to get it removed.Had xrays and ct scans.Fda safety report id# (b)(4).

• Brand Name: SPINAL NERVE STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): Medtronic Inc.
• MDR Report Key: 12142959
• MDR Text Key: 260970432
• Report Number: MW5102413
• Device Sequence Number: 2
• Product Code: GZB
• 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: 07/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 104