MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

Event Type  malfunction  

Event Description

It was reported that the patient believed that their vns generator battery depleted more quickly than expected.The physician indicated that the patient was referred for generator replacement due to low battery and that the vns battery had depleted more quickly than expected.A review of the device history records for the generator showed that no unresolved non-conformances were found and that the device met all specifications for release prior to distribution.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator was replaced prophylactically.The patient's explanted generator was reported to be discarded and therefore return of the suspect product is not expected to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8459797
• MDR Text Key: 140170361
• Report Number: 1644487-2019-00610
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

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: Lay User/Patient
• Device Expiration Date: 10/08/2018
• Device Model Number: 103
• Device Lot Number: 5080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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 Age: 48 YR