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

Device Problem Battery Problem (2885)

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

Event Date 08/17/2017

Event Type  malfunction  

Event Description

Cyberonics battery was at end of life of the battery.

• Brand Name: UNKNOWN
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 6851959
• MDR Text Key: 85353606
• Report Number: 6851959
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1