MAUDE Adverse Event Report: ANS DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Patient stated that they have an ans stimulation device implanted in their skull that is not providing pain relief.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ANS
• MDR Report Key: 17525369
• MDR Text Key: 321065895
• Report Number: MW5132310
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1