MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM XRSCS SYSTEMS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 3360

Device Problems Migration or Expulsion of Device (1395); Application Program Problem (2880)

Patient Problems Paralysis (1997); Sepsis (2067); Urinary Tract Infection (2120); Impaired Healing (2378); Easy Bruising (4558)

Event Date 04/12/2021

Event Type  Death  

Event Description

Paralysis due to spinal cord stimulator operation 04/12/2021.Gastric bypass complications, leg injuries / connections, cerebral palsy.My wife had spinal cord stimulator operation for pain control / leg injuries.(b)(6).Think (b)(6) 2019.(b)(6) went bankrupt.Dr (b)(6) said we just thought they would be bought out.Battery pack migrated, there was no more intel or programming updates.After first saying there was an abbott interface for existing lead, or (b)(6) replaced whole system.My wife was paralyzed from waist down in what was supposed to outpatient day surgery at (b)(6) hospital.She had a lot of bruising as thought she had been dropped, was first told spinal cord bruise would heal up, up to take two years, never healed up.She had foley catheters and suprapubic (at (b)(6) where she taken against her wishes).She had repeated utis and this is basically what killed her, sepsis.They need to stop doing these spinal cord stimulator operations.Left paralyzed and now dead.Paralyzed for two years.Don't know if it was device or surgeon.She was (b)(6), dob: (b)(6) 1965, (b)(6).I am (b)(6).Ref reports: mw5148435 and mw5148436.

• Brand Name: PROCLAIM XRSCS SYSTEMS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL; plano TX
• MDR Report Key: 18204692
• MDR Text Key: 329019051
• Report Number: MW5148434
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3360
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White