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 12/03/2020

Event Type  malfunction  

Event Description

It was reported by the physician that the patient's generator was suspected to have prematurely depleted.The patient had a generator replacement occur.Generator data was reviewed.Using the data, it was found that the generator appeared have depleted more quickly than expected.The explanted device has not been received to date.No additional relevant information has been received to date.

Event Description

Generator analysis was performed.The generator was received pulse disabled and in a vboost condition, due to the pulse generator remaining ¿on¿ post explant.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The generator battery measured 1.931 volts and found to be at an eos=yes condition at the time of explant (b)(6) 2020.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool.A visual assessment on the pcba, performed at the pa test bench, revealed no visual anomalies.The battery was remeasured at the completed of the final electrical test as 2.144 v confirming neos=yes.With the pulse generator case removed and the battery still attached to the pcba, the battery measured 2.255 volts.An adjusted blc was performed for the generator and it was concluded that no anomalies exist and the neos condition is an expected event.The reported premature battery depletion was not confirmed.No additional relevant information has been received to date.

Event Description

The explanted generator was received.Product analysis is being performed.No additional relevant information has been received to date.

Event Description

Per the neurologist and surgeon, the patient had no history of electrocautery.The explanted generator has not been received to date.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: 11047162
• MDR Text Key: 222698178
• Report Number: 1644487-2020-01719
• 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,Followup
• Report Date: 03/30/2021

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: 11/27/2019
• Device Model Number: 106
• Device Lot Number: 5550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Event Location: Other
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 02/05/2021; 03/05/2021
• Supplement Dates FDA Received: 02/04/2021; 03/02/2021; 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR