MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problem Death (1802)

Event Date 08/08/2020

Event Type  Death  

Event Description

It was reported by the nurse practitioner that the patient took their own life.It was noted that the patient was not cremated and had already been interred so the vns products would not be available for return and product analysis.No additional relevant information has been received to date.

Event Description

Per the provider, the patient generator was not able to be interrogated prior to the patient's death.It was noted that the provider was going to attempt to titrate the patient's device; however, did not get the chance.The provider noted that she did not know how much increasing settings would have made a difference as the patient's death was due to a number of factors.The cause of death was reported to be a gunshot wound to the head.The provider noted that she did not believe that the patient's death was related to vns as the patient had anxiety and was not depressed.With the information known to the provider, the patient was receiving stimulation at the time of death.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10495155
• MDR Text Key: 205705723
• Report Number: 1644487-2020-01160
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2019
• Device Model Number: 105
• Device Lot Number: 5185
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 33 YR