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

Model Number 106

Device Problems Energy Output Problem (1431); Premature End-of-Life Indicator (1480)

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

Event Date 12/07/2018

Event Type  malfunction  

Event Description

It was reported that upon interrogation, the patient's generator had been reset to 0ma.The device was turned back on and the battery life indicated ifi=yes condition.The physician was concerned that this device had prematurely depletion as is was only a couple years old.A battery life calculation was performed and estimated that the device had 0.9 years remaining until neos=yes.A review of the device history record indicated that the generator had been laser-routed which has been shown to produce excess debris on the circuit board.This debris may lead to excess current draw from the generator, which can deplete the battery prematurely.No additional relevant information was received to date.

Event Description

Internal device data was reviewed.It was noted that the device reached end of service condition, triggering pulse disablement where the output currents and heart rate detection on the device are disabled as designed.The last voltage value was noted to be around 2.061v (end of service/pulse disablement triggers at <=2.0v).There was no evidence of potential exposure to electrosurgery and impedance values were shown to be within normal limits.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: 8191091
• MDR Text Key: 131206051
• Report Number: 1644487-2018-02387
• 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
• Report Date: 01/27/2019

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: 01/22/2017
• Device Model Number: 106
• Device Lot Number: 203833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 01/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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: 48 YR