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 Tissue Breakdown (2681)

Event Date 11/30/2020

Event Type  Injury  

Event Description

It was reported that the patient has a repositioning surgery scheduled.It was indicated the patient has thin skin and wanted the device implanted deeper.An implant card was received which indicated the device was replaced due to device protrusion.The old device was discarded.The impedance was still good so the surgeon decided to wash out the pocket and replace the battery.It was noted that the generator was hanging approximately half way out of her body which was the reason for replacing and repositioning.The generator was confirmed sterilized prior to distribution.No additional relevant information has been received to date.

Manufacturer Narrative

G4.Date received by manufacturer (mo/day/yr), corrected data- aware date in initial mdr was found to be 11/23/2020.At the time of report the patient info was unknown.Once the patient was identified to be the same patient in this mdr report, correction mdr triggered to report earlier aware date of events.

• 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: 11015401
• MDR Text Key: 221726085
• Report Number: 1644487-2020-01688
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 10/16/2021
• Device Model Number: 106
• Device Lot Number: 6466
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR