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

Model Number 302-20

Device Problems Fracture (1260); Mechanical Problem (1384)

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

Event Date 07/01/2018

Event Type  malfunction  

Event Description

It was reported that patient's device showed high impedance.Patient underwent lead replacement surgery.During surgery, lead pin was removed, cleaned and re-inserted but high impedance did not resolve.Lead pin insertion was checked but the high impedance did not resolve until lead was replaced.After lead replacement.The explanted lead was received.Analysis is underway but has not been completed to date.

Event Description

An abraded opening was noted in the outer silicone tubing.A continuity check performed between the connector pin and the connector ring identified a short circuit condition as a result of the lead coils protruding out of the inner tubing.Based on the appearance of the returned lead portion this condition was most likely caused at explant.The reported lead fracture was not verified.Based on the appearance of the returned lead portion, it is believed that the identified kinks and outer tubing cut/tear openings, stretched coils, and coils protruding out from the inner and the outer silicone tubing, and contact between the positive and the negative lead coils were most likely caused during the explant procedure.Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

• 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: 8058365
• MDR Text Key: 126980964
• Report Number: 1644487-2018-02020
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750092
• UDI-Public: 05425025750092
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2010
• Device Model Number: 302-20
• Device Lot Number: 1928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2007
• 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: 40 YR