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 12/18/2020

Event Type  malfunction  

Event Description

It was reported that the patient¿s generator battery was found to be depleted faster than expected.Device history records were reviewed for the patient's implanted generator and the device passed all functional specifications.Internal data from the patient's generator for 06/09/2020 to 12/18/2020 was received and reviewed.From the parameter list the battery voltage on 12/18/2020 is 2.824 v in green meaning that there is 25% remaining, but the percent of battery capacity used was 7.747% meaning that there should be about 92.253% remaining.It appears that after the 0.5 v offset was removed once the charge consumed surpassed 7.5%, the battery voltage dropped to the 11-25% battery status indicator range.On 12/18/2020, the pbcr using history was 92.253 and the pbcr using vbat was 18.643.Per the equation, vbat = 3.518778 + (92.253)*0.44567 = 44.633 versus 18.643 measured ¿pbcr using vbat¿ on the decoder.Since the measured vbat on the decoder is lower than what the formula gives, the device is below the 95% prediction interval and this is evidence that the battery is depleting faster than expected.

Event Description

It was reported that when the patient was recently seen, their battery status was found to have rebounded to full battery.Internal data from the generator was received and reviewed.During the first 7.5% of the battery life, a 0.5 v off-set is added to the measurement in order to compensate for internal battery impedance at the beginning of life (bol).With the bol high battery impedance (which is not to be confused with high impedance), the battery status indicator is expected to return to the expected battery status indicator without any significant programming changes.The battery voltage is expected to rebound at approximately 10% or higher (up to 15%) of battery consumption.This is consistent with the data received on the patient's generator.No additional relevant information has been received 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: 11286489
• MDR Text Key: 234546942
• Report Number: 1644487-2021-00186
• Device Sequence Number: 1
• Product Code: LYJ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2021
• Device Model Number: 106
• Device Lot Number: 204956
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR