• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL NEUROMODULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL NEUROMODULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN Back to Search Results
Model Number (3771, 3186, 3186)
Device Problems Leak/Splash (1354); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Incontinence (1928); Scar Tissue (2060); Burning Sensation (2146); Burn, Thermal (2530); Electric Shock (2554)
Event Date 08/28/2015
Event Type  Injury  
Event Description
Reporter stated that he had a spinal cord stimulator implanted in 2015. He stated the stimulator battery does not last long. He also said he was shocked, scratched and burned by what looks like a white crust coming out of the battery. He used some home remedies like vinegar and peach tree oil. The burn left a scar. He said sometimes the pain goes all the way down to his pelvis. Reporter said, to this day he does not have sex life because he suffers from erectile dysfunction, he also had bowel and urine incontinence. He has the implant removed last month and some of his issues has improved. He said his foot size went down and now he can wear tennis shoes. He no longer has the incontinence issues except the burning sensation where the battery was every now and then. Reporter contacted st. Jude regarding this issue but he was told they are not willing to talk to him since he has a lawyer.
 
Event Description
Add'l info received from reporter on 01/23/2020, for report number mw5092369. Painful i've suffered for four plus years.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEUROMODULATION
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key9610921
MDR Text Key176060199
Report NumberMW5092369
Device Sequence Number1
Product Code LGW
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,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number(3771, 3186, 3186)
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/17/2020 Patient Sequence Number: 1
-
-