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

Model Number 106

Device Problems Premature End-of-Life Indicator (1480); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  malfunction  

Event Description

It was reported that the physician believed that the patient's generator depleted very quickly and that the generator should have lasted longer.The patient's generator has been implanted for approximately 2.5 years and the battery status indicator is showing 11-25%.A review of the device history records for the generator showed that no unresolved non-conformances were found and that the device met all specifications for release prior to distribution.No further relevant information has been received to date.

Event Description

It was reported that the patient's generator was replaced prophylactically.The explant facility historically discards explanted devices and therefore return of the suspect product is not expected to date.No further relevant information has been received to date.

Event Description

A review of the internal data of the generator showed that the generator battery appeared to have depleted as expected based on the percent battery capacity used and the battery voltage.The percent of battery consumed aligns with the 25% remaining battery indicator seen by the physician that aligns with the battery voltage remaining.Based on the information from the internal data the generator does not appear to be depleting prematurely.Incoming communication was received that the patient experienced a slight increase in seizure frequency and was referred for generator replacement.No known relevant surgical intervention has occurred to date.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: 8242322
• MDR Text Key: 132916487
• Report Number: 1644487-2019-00058
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 203653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 02/12/2019; 04/19/2019
• Supplement Dates FDA Received: 03/07/2019; 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR