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

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

Patient Problem Death (1802)

Event Date 05/01/2020

Event Type  Death  

Event Description

It was reported that the physician gave permission to the family/hospital to turn off the vns for a swallow study.The patient passed away the next day.No other details are available at this time related to the patient¿s passing.No additional relevant information has been received to date.

Event Description

Information was received that the original report of patient death was a misunderstanding with the facility as there was no known vns patient death.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11057317
• MDR Text Key: 223191507
• Report Number: 1644487-2020-01738
• Device Sequence Number: 1
• Product Code: LYJ
• 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: 02/03/2021

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death