MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 03/26/2021

Event Type  Injury  

Event Description

The patient reported experiencing pain at the generator site.The patient noted she saw her managing physician who doesn't think there's an issue with the vns, but the patient wanted to check with the manufacturer.It was noted that the patient underwent generator replacement in (b)(6) 2020, and the patient has also been undergoing electroconvulsive therapy (ect).The patient noted that the generator was disabled as recommended each time for the ect procedures.Additional information was received that the patient was still feeling pain and a shocking sensation, despite the vns being confirmed to be set to 0 ma.The patient has been referred for vns explant surgery.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent vns generator explant, and the patient reports still feeling pain at the previous implant site.The explanted device has not been received by the manufacturer to date.

Event Description

The suspect device was discarded by the explant facility.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11826287
• MDR Text Key: 250836955
• Report Number: 1644487-2021-00664
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2021
• Device Model Number: 106
• Device Lot Number: 205117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 02/09/2022; 04/01/2022
• Supplement Dates FDA Received: 03/04/2022; 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female