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

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/14/2016

Event Type  malfunction  

Event Description

The patient's physician expressed concern that the patient's generator battery has prematurely depleted.The device history record of the generator was reviewed, and the device passed all functional specifications prior to release.It was confirmed that the device was not manufactured during the time that m106 and m105 generators were laser-routed.The physician's office informed that they no longer have access to the programming system used to interrogate the patient's device, and therefore no programming history data is currently available for review.No other relevant information has been received to date.No known surgical intervention has occurred to date.

Manufacturer Narrative

Event description, corrected data: initial report inadvertently listed that the suspect device was not manufactured during the time that m106 and m105 generators were laser-routed.The event description has been corrected, clarifying that the device was manufactured during the time that m106 and m105 generators were laser-routed.

Event Description

The device history record of the generator was reviewed, and the device passed all functional specifications prior to release.It was confirmed that the device was manufactured during the time that m106 and m105 generators were laser-routed.

Event Description

An implant form was received confirming that the patient's generator was explanted and replaced due to battery depletion.The generator was discarded at explant per hospital policies.No other relevant information has been received to date.

Event Description

The data download from the affected generator was received and reviewed.The battery voltage depleted more quickly than expected as compared to the charge consumed measurements (%).According to this data, there is evidence that suggests the device was affected by the laser-routing process used during manufacturing.Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths.Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected.No other 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: 8676376
• MDR Text Key: 148017780
• Report Number: 1644487-2019-01089
• 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
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2017
• Device Model Number: 106
• Device Lot Number: 203824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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: 37 YR