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 12/14/2017

Event Type  malfunction  

Event Description

Patient reported to be referred for battery replacement.The patient's physician expressed concern that the device may be prematurely depleting due to the manufacturing process.Device design history records were reviewed and indicate that the device may have been laser routed.Device programming history data was reviewed.No programming anomalies were observed that would suggest malfunction.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Product analysis for the generator was completed.The product analysis lab confirmed that the generator was at ifi (intensified follow-up indicator)=no condition.A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba.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 allegation of premature end of life.There were no performance of any other type of adverse events found with the pulse generator.

Manufacturer Narrative

Corrected data, initial report: last known system diagnostics inadvertently listed wrong date.

Event Description

Review of the programming history for the device confirmed that the device prematurely depleted.Further information was received that the device was explanted and replaced.The generator has not been received into analysis to date.

Event Description

Product 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: 8181872
• MDR Text Key: 130985824
• Report Number: 1644487-2018-02321
• 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: 03/07/2019

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: 04/16/2017
• Device Model Number: 106
• Device Lot Number: 4349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/21/2018; 01/21/2019; 02/14/2019
• Supplement Dates FDA Received: 01/15/2019; 02/11/2019; 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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: 17 YR