MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

Event Description

During the patient's generator replacement surgery, the surgeon observed an area of exposed lead wire.There was no lead fracture, but there was a large segment of abraded insulation.The lead and generator were explanted.No other relevant information has been received to date.

Manufacturer Narrative

Corrected information, initial report: information stating the following was inadvertently not included: the device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.

Event Description

Per the physician, the cause of the abraded insulation is "complete erosion of insulation - lead failure." the device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.No other relevant information has been received to date.

Event Description

It was noted that the suspect product will be returned, therefore it was not discarded as previously reported.The product has not been received for analysis to date.No other relevant information has been received to date.

Event Description

The explanted products were discarded by the hospital.No other relevant information has been received to date.

Event Description

Product analysis was completed on the generator.Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.Product analysis has not been completed on the lead to date.No other relevant information has been received to date.

Event Description

The explanted lead and generator were received for analysis, but product analysis has not been completed to date.No other relevant information has been received to date.

Event Description

Product analysis was completed on the lead.Note that since a significant portion of the returned lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The connector boot has abraded openings resulting in portions of the manufacturing id tag exposed.Also, abraded openings were noted on the outer and the inner silicone tubing of the returned lead.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9862821
• MDR Text Key: 188027952
• Report Number: 1644487-2020-00490
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2009
• Device Model Number: 302-20
• Device Lot Number: 1527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Event Location: Other
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR