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 10/06/2015

Event Type  malfunction  

Event Description

Report received that a patient's generator had prematurely depleted.The generator had been implanted for less than two years, yet the generator's battery was low.The vns settings were decreased and changed to preserve battery life.Programming history was only available from the day of implant.The patient's medical center would not release programming data, thus the additional data could not be analyzed.The generator was turned off to evaluate efficacy and whether or not the generator would be replaced.A review of the device history record showed the generator had passed all quality inspections and electrical test prior to release for distribution.It also showed the generator had been manufactured with the laser-routing process which has been shown to cause debris leading to excess current draw.No further relevant information has been received and no surgical intervention has occurred to date.

Event Description

It was reported that the patient was replaced due to battery depletion.The explanting facility historically does not return explants, therefore the generator has not been received by livanova to date.Programming history was reviewed.There was evidence that the device was prematurely depleting.No other anomalies were seen.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 additional or relevant information has been seen.

• 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: 6905663
• MDR Text Key: 87856004
• Report Number: 1644487-2017-04516
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 04/19/2019

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: 06/11/2017
• Device Model Number: 106
• Device Lot Number: 4397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• 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