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 Edema (1820)

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported that the patient went for follow-up to turn on his vns device and his incision site looks a little puffy.The patient was referred to have the device explanted but this has not occurred to date.Device history record confirmed the generator was hp sterilized prior to distribution.No additional or relevant information has been received to date.

Manufacturer Narrative

Device return and evaluation will add no value to the investigation.

Event Description

The patient's device was explanted.

• 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: 11046221
• MDR Text Key: 222655109
• Report Number: 1644487-2020-01718
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2021
• Device Model Number: 106
• Device Lot Number: 204785
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR