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 Arrhythmia (1721)

Event Date 12/17/2020

Event Type  Injury  

Event Description

It was reported that the patient was having a prophylactic generator replacement.Prior to the day of surgery, the patient complained or shortness of breath and was concerned vns may be affecting her heart.Additional information was later received that per the neurologist, ekg indicated the patient had left atrial normal sinus rhythm with sinus arrhythmia and possible left atrial enlargement.Implant card was received confirming the patient received a generator replacement.The explanted product cannot be returned as the facility the replacement took place discards all products after surgery.No additional relevant information has been received to date.

Event Description

Information was received that per the provider, none of the events were related to vns.Her settings on the old device were used to set the settings on the new device.No new additional 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: 11147805
• MDR Text Key: 226051488
• Report Number: 1644487-2021-00050
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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: 02/22/2019
• Device Model Number: 106
• Device Lot Number: 204059
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR