MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Energy Output Problem (1431); Premature End-of-Life Indicator (1480)

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

Event Date 10/20/2020

Event Type  malfunction  

Event Description

It was reported that a physician believes the patient's device battery died very fast.It was stated that the patient's battery is very low and unable to perform the desired output.The patient was seen to wear the magnet close to her chest, and in the events and trends data it was seen the magnet stimulation was delivering almost every minute.Programming history showed that the patient's device was not delivering the intended output current.A generator data download also showed that the device appears to be depleting faster than expected per the data and calculation.An ohm's law calculation showed that based on the device battery and impedance value, the device should be able to deliver the intended output.Device history records were reviewed for the generator and the device passed all functional specifications and quality tests and were sterilized prior to distribution.The patient's device has been explanted, however the device has not been received into analysis to date.No additional relevant information has been received to date.

Event Description

Generator analysis was completed.The generator was returned due to prophylactic replacement and energy output to tissue incorrect was also reported however not duplicated in pa lab.The device output signal was monitored for more than 24 hours while the generator was in a simulated body temperature environment.Results showed no variation in output signal and the expected level of output current was seen during the entire monitoring period.The reported allegation of ¿output current low", were however duplicated in the pa lab.Diagnostic values indicated that the output current reported low with the device programmed to a intended higher output current.However, the measured output signal amplitude, both prior to and after the monitoring test demonstrates that the pulse generator is able to deliver the programmed intended higher output current (with the pa load resistor) despite the warning message of a low output condition.The reporter premature battery depletion was not confirmed in pa lab.The measured battery voltage, battery consumption, and battery life calculation supported normal battery depletion.Other than the noted event (low output current), 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.

Event Description

The patient's explanted generator was received into analysis, however 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
• MDR Report Key: 10837339
• MDR Text Key: 216169208
• Report Number: 1644487-2020-01518
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2021
• Device Model Number: 106
• Device Lot Number: 205123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Event Location: Other
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR