MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problem Arrhythmia (1721)

Event Date 11/03/2020

Event Type  Injury  

Event Description

The patient went into cardiac arrest postoperative which required three cycles of cardiopulmonary resuscitation and the patient had to stay in the hospital to be monitored with a holter electrocardiography.The event occurred after a new medication was introduced on the day of implant and following the device being programmed on.The patient's device was disabled at one point after the event but it is currently programmed on and the event has not reoccurred.No other relevant information has been received to date.

Event Description

Information obtained indicating that this is a clinical study patient and the cardiac event was related to vns stimulation/device.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10919993
• MDR Text Key: 218698070
• Report Number: 1644487-2020-01604
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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
• Report Date: 05/06/2021

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: 10/08/2021
• Device Model Number: 1000
• Device Lot Number: 6443
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/31/2020; 04/14/2021
• Supplement Dates FDA Received: 01/07/2021; 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 3 YR