MAUDE Adverse Event Report: UNKNOWN NEUROSTIMULATOR - VAGUS NERVE STIMULATION (VNS); STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Reporter called to report that her vagus nerve stimulator (vns), two years after implanted, has become loose and the device is tilted in her right upper chest, and possibly upside down.In 2019, reporter underwent an additional procedure to have her vns reset and to delay premature battery depletion.Presently, reporter states that her vns is no longer functioning and that it has run out of battery life.Reporter states that the leads connected to the device are causing her some discomfort and that she can feel the vns shifting around in her chest hence, pulling on the connected wires and that she would like the vns removed.

• Brand Name: NEUROSTIMULATOR - VAGUS NERVE STIMULATION (VNS)
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17499721
• MDR Text Key: 321054352
• Report Number: MW5122896
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female