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

Model Number 302-20

Device Problem Mechanical Problem (1384)

Patient Problems No Known Impact Or Consequence To Patient (2692); Fibrosis (3167)

Event Date 04/19/2018

Event Type  malfunction  

Event Description

During the patient's prophylactic generator replacement surgery, the surgeon reported that the lead's outer "sheath" was gone in several places.Multiple system diagnostics were performed and the impedance was within normal limits.The generator was replaced but the lead was left implanted.A review of device history records for the lead shows that no unresolved non-conformances were found.

Event Description

Notes from surgery were received.Per notes, during the surgery, the surgeon noticed that the connecting lead housing was frayed in 4 areas.There was several small openings in the connecting lead housing but no exposure of the wires.Despite this, the lead impedance values were not obstructed.No wires were exposed completely.The surgeon dissected the generator free from significant scar tissue.The surgery was extended by at least 45 minutes due to the difficult nature removing the generator from the entire connecting lead.Surgeon tested the device one more time after connecting existing lead to new generator, which showed the lead impedance value was satisfactory.The explanted generator was received.Analysis is underway but has not been completed to date.

Event Description

The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The electrical performance of the generator, as measured in the lab, will be used to conclude that no anomalies exist and the pulse disabled condition was the result of exposure to an electro-cautery tool, as evident from the burn marks observed on the pulse generator case.Other than the noted events (pulse disabled), there were no additional performance or any other type of adverse conditions found with the pulse generator.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7513206
• MDR Text Key: 108229957
• Report Number: 1644487-2018-00783
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2005
• Device Model Number: 302-20
• Device Lot Number: 8735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/16/2018; 06/28/2018
• Supplement Dates FDA Received: 06/06/2018; 07/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR