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 Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that the patient is scheduled for device explant due to infection.It was reported that the patient was observed to have small 4mm hole over the chest incision site.The patient was experiencing purulent, foul smelling drainage.No redness was observed and the generator could be seen through the skin.The patient had their generator and lead explanted.The generator was noted to be sticking through the patient's skin.The lead was only partially explanted.It was noted that the generator was swabbed and asked to be cultured.The generator was sterilized prior to distribution, and no unresolved nonconformities were identified prior to distribution.The explanted generator and lead have not been received to date.No additional relevant information has been received to date.

Event Description

Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Describe event or problem - correction - product return and device evaluation is not necessary was not included in initial mdr.H3.Device evaluated by mfr?, - correction - code 81, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.Information was not included in initial mdr.

• 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: 10662937
• MDR Text Key: 210996400
• Report Number: 1644487-2020-01366
• 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: 11/25/2020

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: 09/25/2017
• Device Model Number: 106
• Device Lot Number: 4541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Event Location: Other
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 21 YR