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 01/07/2021

Event Type  malfunction  

Event Description

It was reported the patient had a generator replacement after being implanted less than one year.It was reported that the patient had a cranial surgery after vns implantation and the device was noted to have been turned off.It was stated that programming data is available and no errors were observed.The believed cause of the battery depletion is not know per the surgeon.The explanted generator has not been received to date.No additional relevant information has been received to date.

Event Description

Suspect generator was received.Product analysis is being conducted.No additional relevant information has been received to date.

Event Description

Generator analysis was performed.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pcba performed according to functional specifications.With the pulse generator case removed and the battery still attached to the pcba, the battery measured 2.946 volts (ifi=no).A visual assessment on the pcba showed no visual anomalies.Diagaccum consumed memory locations revealed that 29.860% of the battery had been consumed.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: 11278778
• MDR Text Key: 230251021
• Report Number: 1644487-2021-00153
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2020
• Device Model Number: 106
• Device Lot Number: 204658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Event Location: Other
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR