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 03/15/2019

Event Type  malfunction  

Event Description

It was reported that the battery of the patient's vns generator was depleting.The patient's treating medical professional suspected the battery had prematurely depleted.The device history records for the generator were reviewed and show that no unresolved non-conformances were found.The device met all specifications for release prior to distribution and was manufactured with a laser routing process.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Explanted generator was received by product analysis.Product analysis has not been completed to date.

Event Description

Patient underwent generator replacement surgery.The explanted generator has not been received by product analysis to date.

Event Description

Generator product analysis was completed.The product analysis lab confirmed that the generator was at ifi=no condition.A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba.Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions.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.

• 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: 8495994
• MDR Text Key: 141354759
• Report Number: 1644487-2019-00682
• 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: 07/08/2019

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: 07/30/2017
• Device Model Number: 106
• Device Lot Number: 203471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/03/2019; 05/30/2019; 06/25/2019
• Supplement Dates FDA Received: 05/28/2019; 06/20/2019; 07/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2015
• 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: 21 YR