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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Status Epilepticus (4408)

Event Date 06/25/2023

Event Type  Death  

Event Description

It was reported that a patient implanted with vns passed away.During autopsy it was noted that the device was explanted, the date of which is unknown.After some time the device was explanted it was interrogated and error code 6 and generator battery at eos was observed.Additional information was received noting that the clinician assessed that vns is related to the death with concerns that the device became at eos and therefore was not providing any therapy for the patient.It was reported that the patient came into status epilepticus and passed away in the hospital explanted device has not been received to date.No other relevant information has been received to date.

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Manufacturer Narrative

D6a.If implanted, give date; corrected data; initial mdr inadvertently stated incorrect date.F10.Health effect - impact code; corrected data; initial mdr inadvertently omitted data.

Event Description

Internal generator data was received and reviewed.No other relevant information has been received to date.

Event Description

The explanted devices were returned and received to undergo product analysis.Analysis has not been completed to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18152244
• MDR Text Key: 328315108
• Report Number: 1644487-2023-01644
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2024

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: 11/30/2019
• Device Model Number: 106
• Device Lot Number: 204320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/19/2023; 02/15/2024; 04/02/2024; 05/01/2024
• Supplement Dates FDA Received: 12/14/2023; 03/11/2024; 04/26/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 18 YR
• Patient Sex: Female