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

The patient's epileptologist expressed concerns regarding this patient who is implanted with a laser-routed device.It was reported that the physician believes this patient's generator is prematurely depleting.The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process.The device met all specifications for release prior to distribution.Data from the patient's device was reviewed and does not confirm that the battery depleted more quickly than expected.The charge consumed (%) did not deplete more quickly than expected as compared to the battery voltage measurements.No further relevant information has been received to date.

Event Description

The patient¿s neurologist reported that they are convinced that this patient is not receiving therapy.No other relevant information has been received to date.

Event Description

Based on available data that was provided premature battery depletion is not verified.The % of battery capacity used and % of battery capacity remaining appears to match the expected values.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: 8183937
• MDR Text Key: 130986209
• Report Number: 1644487-2018-02353
• 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
• Report Date: 04/26/2019

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: 07/30/2017
• Device Model Number: 106
• Device Lot Number: 203465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 02/13/2019; 04/01/2019
• Supplement Dates FDA Received: 03/08/2019; 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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