MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT PROCLAIM DRG STIMULATOR; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 10/28/2019

Event Type  malfunction  

Event Description

Breakage of lead for dorsal root stimulator.Patient has complex regional pain syndrome with reasonable control with a dorsal root stimulator.One lead had break in the wire ¿atraumatically¿ with normal activity ~2 years after implantation.This rendered the device ineffective and resulted in having to surgically remove the lead and place another with direct visualization with a laminotomy in the lumbar spine.Fda safety report id # (b)(4).

• Brand Name: ABBOTT PROCLAIM DRG STIMULATOR
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL; abbott park IL 60064
• MDR Report Key: 9686781
• MDR Text Key: 178583342
• Report Number: MW5092871
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 73