MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 302

Model Number 302-20

Device Problems Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979); Scratched Material (3020)

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

Event Date 01/29/2016

Event Type  malfunction  

Event Description

It was reported that a generator and a lead have been explanted on (b)(6) 2016 due to lack of efficacy and were not replaced.The explanted devices were returned to the manufacturer for analysis on 02/08/2016.Review of manufacturing records confirmed that the devices passed all functional tests prior to distribution.The review of the available programming history data showed that the patient's device was programmed intentionally on low settings and inefficient duty cycle during the first 3 months after the implant.After that the device was reprogrammed properly.The cause of this dosing option remains unknown at this time.The device was switched off on (b)(6) 2008.The analysis of the generator concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.A part of the lead attached to the generator was returned for analysis in one piece.The lead's electrodes were not returned for evaluation.The contact between the setscrew and the lead pin was confirmed.The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector.The exact point in time of when this occurred is unknown.The lead connector has partial detachment at the ring/backfill interface.The reason for this condition is unknown.No adverse effect was identified on the device performance as a result of this condition.The outer and inner silicone tubing is abraded open.The inner silicone tubing of the positive coil appears to be abraded/torn open.The lead coils are protruding out of the inner silicone tubing close to the boot.The inner silicone tubing of both lead coils appears to be torn open close to the boot resulting in portion of the lead coils exposed inside the outer tubing.Abrasions most likely caused by the presence of tie-downs.The lead coils have a spiral and stretched appearance along the lead body.Abrasions were noted on the connector boot and on the silicone tubing of the lead coils past the electrode bifurcation.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5543624
• MDR Text Key: 42507284
• Report Number: 1644487-2016-00672
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2016

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: 03/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2007
• 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