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

Device Problems Energy Output Problem (1431); Temperature Problem (3022)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient reported they turned up their drg implant and it gave them a lot of pain and the issue began a week ago or maybe 2 weeks ago.Patient reported the drg got very very hot.Agent redirected patient to abbott drg/scs customer service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRG IMPLANT
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17362813
• MDR Text Key: 319503086
• Report Number: MW5119688
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1