MAUDE Adverse Event Report: ST. JUDE'S MEDICAL OPERATIONS (M) SDN BHD / ABBOTT MEDICAL PROCLAIM ; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 3884

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Seizures (2063); Burning Sensation (2146); Loss of consciousness (2418)

Event Date 05/07/2019

Event Type  Injury  

Event Description

I was exiting shower when all of the sudden i experienced intolerable burning sensation inside my body followed by a seizure and collapse to floor loosing consciousness for approx fine mins.The shocking of device caused seizure which was followed by loss of bowel control and consciousness.I went to primary care dr for treatment and documentation.I also notified device rep from abbott.He acknowledged my injuries which were documented in photos and he measured them as well.He troubleshot the device and stated that it had failed.I was told that they would figure out what happened and get back to me.That never happened.In august i was put back on high level, so opiates for loss of pain control from failed device.I was able to reach device rep and hopefully get replacement done.I went to get referral from pain dr and a number of xrays were taken.I was instructed that device had failed and needed a new one.Then i went to implanting device who turned out of network all the sudden.I attempted to see two other surgeons with no success.I am a 100% disabled veteran and unable to do anything a normal person would as i cannot get any resolution from device mfr.Fda safety report id# (b)(4).

• Brand Name: PROCLAIM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ST. JUDE'S MEDICAL OPERATIONS (M) SDN BHD / ABBOTT MEDICAL
• MDR Report Key: 9511287
• MDR Text Key: 172606276
• Report Number: MW5091845
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3884
• Device Catalogue Number: 3884
• Device Lot Number: 6738572
• 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): Other; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 90