MAUDE Adverse Event Report: CYBERONICS, INC. VNS THERAPY PULSE; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 102

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

Event Description

Pt was in surgery to have a vagal nerve stimulator generator change when the surgeon noted an area of exposed lead wire.There was no lead fracture, but a large segment of abraded insulation according to the surgeon.This defective lead wire and generator was removed.Fda safety report id# (b)(4).

• Brand Name: VNS THERAPY PULSE
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS, INC. ; houston TX 77058
• MDR Report Key: 9706323
• MDR Text Key: 179423393
• Report Number: MW5092966
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR