MAUDE Adverse Event Report: LIVANOVA USA, INC. VNS THERAPY® DEMIPULSE DUO® MODEL 104 GENERATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)

Model Number 104

Device Problem Battery Problem: Low Impedance (2973)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The new generator was connected to the leads and tightened with the screwdriver.The generator was placed in the pocket with the lead coiled behind it with no kinks.Once in the pocket, it was tested.The new generator was showing low battery/ eos, an obvious malfunction.Multiple attempts to disconnect and reconnect the leads were made.Livanova it support was called from the or for the with no resolution.

• Brand Name: VNS THERAPY® DEMIPULSE DUO® MODEL 104 GENERATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 16183473
• MDR Text Key: 307483576
• Report Number: 16183473
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2022

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 Operator: Health Professional
• Device Model Number: 104
• Device Catalogue Number: 104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Weight: 99 KG