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 02/14/2019

Event Type  malfunction  

Event Description

Physician reported that the patient's generator was prematurely depleting.The patient underwent generator replacement due to depleting battery.The explanted product has not been received by product analysis to date.A review of device history records for the generator shows that no unresolved non-conformances were found.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

Further information was received confirming that electrocautery was not used on the patient at time of implant or since device implant.Generator product analysis was completed.The product analysis lab confirmed that the generator was at premature end of life ifi(intensified follow-up indicator)=yes.A visual assessment on the pcba showed no visual anomalies.A number of test parameters, related to ¿supply current¿, were found to be out of specification.Based on the postburn electrical test results, the ¿supply current¿ test measurements demonstrate an increased current consumption for the pulse generator.The capacitor¿s (c1) increase in leakage current resulted in increased current consumption (out of specification) for both standby and pulsing modes of operation, and may have been the contributing factor for the reported allegation of premature end of life.The cause for the capacitor¿s (c1) increase in leakage current could not be determined.There were no other performance of any other type of adverse events found with the pulse generator.

• 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: 8443443
• MDR Text Key: 139549417
• Report Number: 1644487-2019-00563
• 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
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2018
• Device Model Number: 106
• Device Lot Number: 203885
• 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: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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