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 Seizures (2063)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

It was reported that a patient would be having an urgent battery replacement due to low battery.The generator was suspected to have prematurely depleted as the physician's office was notified that the generator may have "shorter than expected battery longevity".The generator was found to have low battery at the patient's last interrogation and it was reported that the patient was also experiencing a sudden increase in seizures.A battery life calculation was performed to estimate remaining battery life with the programming data made available to the manufacturer's, and did not estimate that the device would have reached low battery at this time.Review of the device history records confirmed that the device was laser-routed and is susceptible to prematurely deplete.The device passed all quality inspections prior to distribution.Follow up with the physician's office noted that the increased seizures were first noted a "couple months" before per the patient.The last diagnostics provided were from mid-october and showed that the device was functioning at intended.No additional relevant information was received to date.

Event Description

An implant card was received for the patient's battery replacement which was indicated to be prophylactic.The generator was not expected for return as the facility does not keep explants and discards products after every case.Decoded programming data was also reviewed and confirmed that the battery is depleting more quickly than expected.The charge consumed (%) depleted more quickly than expected as compared to the battery voltage measurements.No device was returned for analysis.No additional, relevant information was received to date.

Manufacturer Narrative

Device return, corrected data: follow-up report #1 inadvertently indicated that the device had not been returned to date.

Event Description

The device was returned for analysis.Analysis was completed.Visual examination of the device showed markings typical of surgical procedures.No other surface abnormalities were noted.The generator was opened and a visual assessment of the pcba showed contaminates on the trimmed edge of the pcba.Both interrogation and diagnostic tests were performed with the expected results.The device output signal was monitored for more than 24 hours while placed in a simulated body temperature environment.The results showed expected levels of output signal and the device performed according to functional specifications.Based on the electrical tests performed, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths were established between the copper edged on the trimmed edge of the pcba, contributing to supply current conditions.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported premature end of life.No additional relevant information was 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: 8246819
• MDR Text Key: 133057512
• Report Number: 1644487-2019-00075
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2017
• Device Model Number: 106
• Device Lot Number: 203806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR