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 10/01/2018

Event Type  malfunction  

Event Description

It was reported that the patient's mother was surprised about how fast the patient's generator battery had depleted.The device history records for the generator were reviewed and show that no unresolved non-conformances were found.The device met all specifications for release prior to distribution and was not manufactured with the laser routing process.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Manufacturer Narrative

Initial reporter.Corrected data: initial report inadvertently listed the patient's neurologist as the initial reporter instead of the patient's mother.

Event Description

Based on available internal data of the generator that was provided, premature battery depletion was not verified.The % battery capacity remaining appears to match the expected values based on settings patient was programmed to.The internal data did not exhibit any accelerated drops in battery voltage or any reason to suspect that the device depleted prematurely or was struck by electrocautery or other electrosurgical equipment.The battery voltage rebounded from a lower battery voltage to a higher battery voltage, likely due to the device being programmed off for approximately 3 months.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: 8539357
• MDR Text Key: 142748063
• Report Number: 1644487-2019-00761
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Model Number: 106
• Device Lot Number: 204031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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: 44 YR