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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported in an article (tufo, t., mannino, s., fuggetta, f., barone, d.G., cioni, b.Vns for drug-resistant epilepsies: long term results compared with patient/caregiver satisfaction (10586).North american neuromodulation society 19th annual meeting.2015.207.) that 23 patients with vagal nerve stimulation (vns) for drug-resistant epilepsy were considered "unchanged" by their physician.At long term follow-up, vns was ineffective in less than 26 patients and that less than 21 patients/caregivers were not satisfied.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN VAGAL NERVE STIMULATION (VNS)
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530035
• MDR Text Key: 321453521
• Report Number: MW5136955
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 05/12/2016

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