MAUDE Adverse Event Report: LIVANOVA USA, INC. VNS THERAPY ASPIRESR MODEL 106 GENERATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Catalog Number 106

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

Device was implanted, when tested the device did not work.Rep was called to try and figure out what was wrong with the device.Device explanted and returned in original packaging to service coordinator.

• Brand Name: VNS THERAPY ASPIRESR MODEL 106 GENERATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 16643971
• MDR Text Key: 312332613
• Report Number: 16643971
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 106
• Device Lot Number: 143843
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Male