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

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

Per report, the vagal nerve stimulator was not functioning properly.A prior evaluation by a cyberonics representative showed impedance values in his system greater than 10,000 ohms-indicating a break in his electrode.So the patient was taken to the or for removal and replacement of the nerve stimulator and lead.The device will be returned to the cyberonics representative.Manufacturer response for cyberonics vagal nerve stimulator, cyberonics vagal nerve stimulator (per site reporter).

• Brand Name: VNS THERAPY SYSTEM
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS, INC; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 7128024
• MDR Text Key: 95193619
• Report Number: 7128024
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 106
• Other Device ID Number: LEAD 01227
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR