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 12/01/2018

Event Type  malfunction  

Event Description

It was reported that the physician believes this generator is prematurely depleting.Programming history was reviewed for the generator.Premature battery depletion was not verified although full programming history was not provided.Device history records were reviewed.The generator was laser routed and was susceptible to premature depletion.No additional information has been received to date.

Event Description

Updated programming history was received and reviewed.The patient has not reached the 25% indicator so premature battery depletion could not be assessed.There were no anomalies seen.No additional or relevant information has been received to date.

Event Description

It was reported that the physician believed that the patient was not receiving therapy.No additional relevant information has been received.

Event Description

It was reported that the patient had a generator replacement.It was reported that the explanted generator was discarded.No additional relevant information has been received to date.

Manufacturer Narrative

Explant date - correction - explant date was not included in supplemental 3 mdr.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8184030
• MDR Text Key: 130986042
• Report Number: 1644487-2018-02354
• Device Sequence Number: 1
• Product Code: LYJ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Event Location: Other
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: 13 YR