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 06/25/2019

Event Type  malfunction  

Event Description

It was reported that the patient's neurosurgeon and father requested a detailed report of the patient's generator as they believe the generator battery depleted prematurely.The patient was referred for vns generator replacement.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 and was manufactured with the use of laser routing.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Internal data from the patient's generator from implant date until (b)(6) 2019 was received and reviewed.Per the internal data, there was a discrepancy between the percent battery charge consumed and the measured battery voltage.The percentage of the battery consumed was approximately 39% consumed while the battery voltage indicated that the generator was at near end of service = yes (neos=yes) condition, indicating that the percent battery capacity remaining was less than 5% remaining (95% consumed).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
• 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: 8781095
• MDR Text Key: 150719566
• Report Number: 1644487-2019-01349
• Device Sequence Number: 1
• Product Code: LYJ
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 203365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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: 17 YR