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

Model Number 103

Device Problem Insufficient Information (3190)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was initially reported that a patient was having their device replaced and no information regarding the reason for replacement was received.Information regarding the return of the generator was received and generator was received into analysis, with reason for explant on the return product form noted to be due to"hardware failure".Device history records were reviewed for the generator and any defects and changes that were found during manufacturing of the device were signed off on and approved prior to the product being released.The device ultimately passed all functional specifications and quality tests and were sterilized prior to distribution.Per the explant surgeon, no further details from this replacement are known and it was stated that the only note regarding the patient's generator replacement was that the generator was at end of life.Per the referring physician, the hardware failure was in reference to the generator battery being depleted and the battery life being too short and only lasting two years, when he thought it would last 5 years.However, it was found that the physician was referring to the patient's recent generator which was reported to have prematurely depleted, reported in mfr report# 1644487-2018-00490.The generator has been received into analysis and product analysis has not been completed at this time.No additional relevant information has been received to date.

Event Description

Generator analysis was completed and approved.The generator was explanted and returned due to listed "hardware failure - generator performance issue".These allegations were not duplicated in the product analysis (pa) lab.The generator would not interrogate prior to decontamination or at the pa ben and therefore the ram and flash data download, system diagnostics, final electrical test, and diagnostic vbat calculation could not be performed.The generator case was removed and the with the battery still attached to the printed circuit board assembly (pcba), the battery was measured and confirmed an end of service (eos) condition.The postburn electrical test results showed the pcba performed according to functional specifications.A manufacturer's battery life calculation (blc) resulted in expected time to near end of service (neos) = 0.0 years.An incomplete programming/diagnostic history indicates the calculation does not use all the data needed to make an accurate estimation.The pa worksheet, blc, and programming history database (phd) were reviewed and no anomalies were found.Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the eos condition is an expected event.Other than the noted event (no communication due to a depleted battery), there were no additional performance or any other type of adverse conditions found with the generator.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: 8773479
• MDR Text Key: 150578531
• Report Number: 1644487-2019-01293
• Device Sequence Number: 1
• Product Code: LYJ
• 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
• Report Date: 08/05/2019

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: 04/21/2011
• Device Model Number: 103
• Device Lot Number: 2386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2009
• 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: 36 YR