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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/01/2021

Event Type  Injury  

Event Description

The drg implant caused extra surgical pain which has not resolved.The unit is so painful to my knee i can not even turn it on.The data on efficiency has been fudged and is not valid.Fda safety report id # (b)(4).

• Brand Name: ABBOTT DORSAL ROOT GANGLION STIMULATOR
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 11700562
• MDR Text Key: 246964882
• Report Number: MW5100888
• Device Sequence Number: 1
• Product Code: PMP
• 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: 04/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR