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 11/20/2018

Event Type  malfunction  

Event Description

A physician's assistant stated that a patient's battery had reached a 25% battery indicator and questioned whether the device was depleting as expected.A review of device history records for the generator shows that the device was potentially laser routed.The device met all specifications for release prior to distribution.A battery life calculation and programming history review were performed and no programming anomalies were observed that would suggest malfunction.No additional relevant information has been received to date.

Manufacturer Narrative

Evaluation codes, corrected data: method coding inadvertently not added in initial report.

Event Description

Review of the data download confirmed that the battery voltage depleted faster than expected.

Event Description

Patient was referred for generator replacement.No known surgical intervention has occurred to date.

Event Description

Generator product analysis was completed.The reported allegation of premature end of life was confirmed by product analysis.The pulse generator was opened.A visual assessment on the pcba, performed at the pa test bench, showed contaminates on the trimmed edge of the pcba (tab removed).No other visual anomalies were identified.Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation), and may have been the contributing factor for the reported allegations of premature end of life.There were no other performance of any other type of adverse events found with the pulse generator.

Event Description

Patient underwent generator replacement surgery.The explanted generator was received by product analysis.Product analysis has not been completed 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: 8157453
• MDR Text Key: 130185532
• Report Number: 1644487-2018-02279
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2017
• Device Model Number: 106
• Device Lot Number: 4407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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: 16 YR