MAUDE Adverse Event Report: LIVANOVA USA, INC. VNS THERAPY PULSE MODEL 102 GENERATOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)

Model Number 102

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Device malfunction while preparing for mri.Device turned off for mri.While walking into the mri area patient reported a strong vns stimulation.

• Brand Name: VNS THERAPY PULSE MODEL 102 GENERATOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION)
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 10319603
• MDR Text Key: 200229334
• Report Number: 10319603
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1