MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2019

Event Type  malfunction  

Event Description

A report was received that during a prophylactic generator replacement for a patient, the surgeon found a small slit in the tubing and could visibly see fluid in the lead.However, the physician questioned whether the fluid in the lead could have been the reason for the shorter life span of the generator at the patient's pre-op settings.A full revision was performed at this time.A manual manufacturer's battery life calculation was performed with additional data provided by the sales representative and operating room specialist.The result revealed expected time to neos = 4.8 years.Device history records were reviewed and the device passed all functional specifications and quality tests and were sterilized prior to distribution.The suspect device has been explanted but has not been received for analysis to date.No additional relevant information has been received to date.The fluid leak is reported in mfg report 1644487-2019-01323 as there is no confirmed relationship between the generator's premature battery depletion and the fluid leaks, as impedance was within normal limits prior to surgery.

Event Description

Product was received into analysis however product analysis has not been completed to date.No additional relevant information has been received to date.

Event Description

Generator product analysis was completed.The generator diagnostics were as expected for the programmed settings.The battery was measured during the completion of the final electrical test and showed no low battery, at ifi (intensified follow up indicator) = no, and exhibited normal battery consumption.The pa worksheet, battery life calculation, and programming history data were reviewed and no anomalies were found.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications and there were no performance or any other type of adverse condition found with the generator.The allegation of premature battery depletion was confirmed invalid.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 8773208
• MDR Text Key: 150578968
• Report Number: 1644487-2019-01299
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 0105425025750030
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2018
• Device Model Number: 103
• Device Lot Number: 5087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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: 8 YR