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

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problems Syncope (1610); Death (1802)

Event Date 11/11/2020

Event Type  Death  

Event Description

It was reported that the patient was in the icu.Patient's generator was interrogated to be at eos (pulse disabled).Blc was performed and the estimate years did not match current battery status.Dhr was reviewed and the generator was observed to have been laser routed.The patient was found to be unresponsive on the floor.The patient was assumed to have had a seizure; however, this was not confirmed by a physician.The patient was reported to have passed away a few weeks ago.It was noted that the patient had not been seen by a neurologist for over a year and was scheduled to see a neurologist so the patient could be referred for replacement.It was noted that patient passed away prior to seeing the physician.No additional relevant information has been received to date.

Event Description

Per the provider, the cause of death is not known.Per the provider, there was no suspicion of premature depletion having occurred for the patient's generator.It was noted that the patient was last since in 2019 and no issues were observed with vns.It was noted that the patient was difficult to get into the office after 2019 due to covid and the patient living at a nursing home.No additional information could be provided regarding the patient being unresponsive.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: 10950487
• MDR Text Key: 219762725
• Report Number: 1644487-2020-01635
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2017
• Device Model Number: 106
• Device Lot Number: 203831
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR