MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC SPINAL CORD NERVE STIMULATOR

Model Number 997714

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/31/2017

Event Type  Injury  

Event Description

My name is (b)(6) and i am in (b)(6) parked in front of (b)(6) and my medtronic spinal cord nerve stimulator is sending electrical currents throughout my entire body when the implant was for my right leg only.

• Brand Name: MEDTRONIC SPINAL CORD NERVE STIMULATOR
• Type of Device: MEDTRONIC SPINAL CORD NERVE STIMULATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6456397
• MDR Text Key: 71744127
• Report Number: MW5068870
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 997714
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 65