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

Device Problems Loose or Intermittent Connection (1371); Firing Problem (4011)

Patient Problem Failure of Implant (1924)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

The patient reported that she no longer had sensation that the vagal nerve stimulator was firing.On [dated redacted], the patient was taken to the or for revision of the stimulator.Findings during the surgical procedure: functional lead with a loose connection to the generator.Due to a possible malfunction of the locking screw, it was replaced, and a new model 1000 generator and torque wrench was used to tighten and locked the lead.

• Brand Name: VAGUS NERVE STIMULATOR BATTERY
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 16203653
• MDR Text Key: 307677455
• Report Number: 16203653
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White