MAUDE Adverse Event Report: MEDTRONIC SPINAL STIMULATOR

Model Number 37714

Device Problems Failure to Charge (1085); Failure to Power Up (1476); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Respiratory Distress (2045); Shock (2072)

Event Date 12/06/2012

Event Type  Injury  

Event Description

Device stopped working period - will not charge, will not come on.Started sending stabbing shocks down spine all the way to legs and feet.Cannot get any relief at all or sleep.Affects my breathing as well and only happens when i lay down to sleep.Was a (b)(6) case and i have no insurance since that case is closed and would like information to get this medtronic spinal stimulator model #37714.

• Brand Name: SPINAL STIMULATOR
• Type of Device: SPINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6188739
• MDR Text Key: 62939092
• Report Number: MW5066801
• Device Sequence Number: 1
• 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: 12/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37714
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 36 YR
• Patient Weight: 95