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 Problems Hematoma (1884); Insufficient Information (4580)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the event requiring drainage surgery is not related to the functionality or delivery of therapy of the device.

Event Description

It was identified via clinic notes that the patient underwent vns site incision and drainage surgery approximately 1.5 weeks after generator replacement surgery.Device history record was reviewed for the suspect generator.The device was confirmed to be sterilized prior to distribution, and there were no unresolved nonconformance found prior to distribution.Product return and device evaluation is not necessary as the reported drainage is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.

Event Description

Additional information was received indicating that the cause for the drainage procedure was due to a hematoma, which the surgeon assessed was caused by patient manipulation.It was noted that the surgery was both for patient comfort and to preclude a serious injury.No additional relevant 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: 12002901
• MDR Text Key: 256314659
• Report Number: 1644487-2021-00821
• 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: 07/15/2021

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: 03/05/2021
• Device Model Number: 106
• Device Lot Number: 6179
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR