MAUDE Adverse Event Report: LIVANOVA USA, INC. VNS THERAPY® SENTIVA¿ MODEL 1000 GENERATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 1000

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 12/01/2017

Event Type  Injury  

Event Description

The patient had a vagal nerve stimulator battery replaced in surgery.After the patient was taken to her room for post-care, the nurse noted that the newly replaced battery showed message which stated: "eos- end of service".The neurosurgeon was notified and the patient was scheduled to replace the battery once again.The manufacturer's representative was in surgery during the battery placement.

• Brand Name: VNS THERAPY® SENTIVA¿ MODEL 1000 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: 7205248
• MDR Text Key: 97728992
• Report Number: 7205248
• 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: 01/05/2018,01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2019
• Device Model Number: 1000
• Device Catalogue Number: GMDN 34210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 47 YR