MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291); Device Inoperable (1663)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/22/2014

Event Type  malfunction  

Event Description

It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the surgeon stated that the vns patient¿s lead may be fractured.Operative notes indicate that the setscrew was tightened appropriately and the replacement generator was tested with the existing lead.Diagnostic results consistently provided elevated impedance values.Pre-operative diagnostics could not be performed due to the end of service condition.The patient¿s generator was replaced and the procedure was completed with the device disabled.The patient was referred for lead replacement, but no known surgical interventions for the lead fracture.It was noted that the patient frequently has twisting and jerking neck movements which may have contributed to the lead fracture and that the patient has been having coughing fits.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015.Preoperative system diagnostic results showed high impedance (dcdc - 6).System diagnostic results with the replacement lead and existing generator showed lead impedance within normal limits (dcdc - 1).The surgeon confirmed that the lead had been completely and securely inserted into the generator header.It was noted that once the neck incision site was opened, it appeared that the anchor tether was out above the carotid sheath where the electrodes were implanted.The explanted generator and lead were returned to the manufacturer for analysis.There was no indication from the returned generator that an end of service or failure to program condition existed.The device communicated normally and performed according to functional specifications.No abnormal performance or any other type of adverse condition was found.Follow-up with the physician's office indicated that the programming system was working fine without any issues.Analysis of the returned lead confirmed discontinuity of quadfilar coil in the electrode region.Pitting was observed on the coil surface.Abraded openings of both inner tubes were observed near the break location.The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4430479
• MDR Text Key: 5374679
• Report Number: 1644487-2015-03656
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Model Number: 302-20
• Device Lot Number: 2340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2009
• 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: 24 YR