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

Model Number 106

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

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

Event Date 06/21/2016

Event Type  malfunction  

Event Description

It was reported from physician stating that the patient was interrogated with eos (end of service) indicated after a year with no follow up.The physician did not think this was correct and programmed the device on to the previous settings.The patient's device was manufactured during a period in which a laser routing practice was implemented, a process which was now known to lead to current leakage on the device's circuit board.Additionally, tablet data provided from the physician was reviewed for evidence of premature battery depletion, and it was found that the device had exhibited eos faster than expected.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Age - updated for event date to reflect manufacturing date; date of event - updated for event date to reflect manufacturing date.

Event Description

The patient's device was explanted.The explanted device has not been received to date.No further 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
• MDR Report Key: 9130785
• MDR Text Key: 160491541
• Report Number: 1644487-2019-01882
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2021

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: 01/24/2017
• Device Model Number: 106
• Device Lot Number: 203833
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 11/11/2019; 08/31/2021
• Supplement Dates FDA Received: 11/11/2019; 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR