MAUDE Adverse Event Report: LIVANOVA USA INC. VAGUS NERVE STIMULATOR (VNS); STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)

Model Number 57996

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Patient called about a vagus nerve stimulator from livanova model 57996.She had one and it died and she started having symptoms again.The battery was so dead they couldn't get any readings.Patient doesn't do well on the medicine.The device is to stop seizures.Patient said she had them both replaced within a two week period.She needs the therapy turned on.Redirected her to livanova."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".Ref report: mw5153522.

• Brand Name: VAGUS NERVE STIMULATOR (VNS)
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): LIVANOVA USA INC.
• MDR Report Key: 19040344
• MDR Text Key: 339477390
• Report Number: MW5153523
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 57996
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Patient Sequence Number: 1