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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/28/2017

Event Type  malfunction  

Event Description

Vagus nerve stimulator generator live life, the generator battery changed today.

• Brand Name: VNS THERAPY
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 6954818
• MDR Text Key: 89513156
• Report Number: 6954818
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES