MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Event Description

It was reported that this new and unused generator was interrogated during a patient¿s replacement surgery and was fine upon initial interrogation; however, after implanting the generator it showed low battery.It was confirmed that electrocautery was used after the generator was placed in the patient's chest.A different generator was implanted in the patient and was stated to be perfectly fine.The programming data was received and reviewed.The data revealed two interactions with the generator, a programming operation and a system diagnostic operation.The battery status showed ok for the system diagnostic operation.The programming event shows no battery status, lead impedance, or other device information, as this information is not assessed during this interaction by the software.A review of device history records for the generator shows that no unresolved non-conformances were found.The device met all specifications for release prior to distribution.The generator has been received by the manufacturer.Analysis is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed for the returned generator.Review of the as received data did indicate a premature end-of- life was noted on the day after implant.Initial interrogation of the generator indicated that the reboot counter was reset due to a bor (brown out reset).Electrical test results showed that the pulse generator performed according to functional specifications.Visual examination performed at the bench revealed two small area of possible burn marks on generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant.This resulted in the observed ¿pulse-disable¿ condition.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 8561080
• MDR Text Key: 145507476
• Report Number: 1644487-2019-00817
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: 1000
• Device Lot Number: 204565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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