MAUDE Adverse Event Report: MEDTRONIC INC. MEDTRONIC RESTORE ULTRA 37712; SPINAL CORD STIMULATOR

Model Number 37712

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 04/11/2018

Event Type  Injury  

Event Description

I have a medtronic restore ultra 37712 spinal cord stimulator, serial #(b)(4) surgically implanted (b)(6) 2013.On (b)(6) 2018 i received a strong shock while charging the battery.This is the fourth shock i have received since (b)(6) 2017.On (b)(6) 2017 the shock was severe and my entire body shook, i was unable to speak and my husband had to hold me up.This was witnessed by a medtronic employee in my physician's office.The three subsequent shocks occurred at home during charging sessions.

• Brand Name: MEDTRONIC RESTORE ULTRA 37712
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 7502189
• MDR Text Key: 107977089
• Report Number: MW5077105
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• 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: 05/07/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37712
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 69