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 12/16/2020

Event Type  malfunction  

Event Description

It was reported that a patient implanted in may is showing 50% battery life and the physician is trying to determine if the battery is depleting normally or if it could be depleting prematurely.No additional relevant information has been received to date.

Event Description

The 25% indicator was displayed due to the effect of the high settings and high duty cycle on the battery voltage, and isn¿t indicative that the battery is depleting faster than expected.In actuality, based on the data from the last office visit it is more likely that close to 50% of battery capacity remains.

• 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: 11141395
• MDR Text Key: 225826289
• Report Number: 1644487-2021-00046
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2022
• Device Model Number: 106
• Device Lot Number: 205179
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR