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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL / ABBOTT LABORATORIES NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR
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ST JUDE MEDICAL / ABBOTT LABORATORIES NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR Back to Search Results
Model Number 3660,3383,3383,3228
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900)
Patient Problem Electric Shock (2554)
Event Date 07/29/2018
Event Type  Injury  
Event Description
I had a st jude abbott spinal cord stimulator implanted on (b)(6) 2017.A few months later, i turned device off when having a mammogram.When i tried to turn it back on, it wouldn't connect.Saw the st jude rep and he said several of the contacts weren't working.Luckily he was able to increase the strength of the program and i was up and running.Then a few weeks ago, while driving i experienced severe pulsating shocks down my right arm.They would last for about 30 seconds, stop, and then start again.When i got home i tried to turn device off and for about an hour, i felt i was being electrocuted.Eventually, i was able to connect to the controller and stop the shocks.Saw surgeon who reviewed x-rays and determined everything was in place.The final comment was that i "drew the short straw" and the device simply stopped working.Because of potential risks with removal, (i'm (b)(6) y/o) i'm thinking i might just leave it intact.Don't know what risks that entails.
 
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Brand Name
NEUROSTIMULATION SYSTEM
Type of Device
SPINAL CORD STIMULATOR
Manufacturer (Section D)
ST JUDE MEDICAL / ABBOTT LABORATORIES
MDR Report Key7818515
MDR Text Key118410852
Report NumberMW5079390
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3660,3383,3383,3228
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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