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 08/14/2015

Event Type  malfunction  

Event Description

It was reported that the physician believed the patient's generator had prematurely depleted.A review of the available data was unable to assess premature depletion due to lack of more recent data.The generator's device history records were reviewed.The generator passed final quality and functional specifications.The generator was laser-routed.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

Further programming data was received that provided evidence of premature battery depletion.From a previous internal investigation, it is known that some laser-routed devices may be susceptible to premature battery depletion.The observed premature battery life indicator was most likely caused by conductive debris from the laser-routing process, which resulted in current leakage paths and premature depletion.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient underwent prophylactic generator replacement.Product return is not expected per hospital policy.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: 8185761
• MDR Text Key: 131153455
• Report Number: 1644487-2018-02361
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2017
• Device Model Number: 106
• Device Lot Number: 203476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• 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 Age: 12 YR