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

Model Number 3664

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Burn, Thermal (2530); Shock from Patient Lead(s) (3162)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Revision of implanted drg stimulator for chronic pain resulted in abnormal stimulation, shocks and burning; battery abnormally protruded from pocket and caused constant burning.Devices failed to cover chronic pain/injury.X-ray revealed repeat lead migration even after revision surgery.

• Brand Name: PROCLAIM
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 8106350
• MDR Text Key: 128645137
• Report Number: MW5081629
• Device Sequence Number: 2
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/25/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3664
• Device Catalogue Number: MN10450-50A
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 57