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

Model Number 302-30

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Twitching (2172); Shock, Surgical (2267); Neck Pain (2433)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (impedance value ¿ 8180 ohms).The patient presented with an increase in seizure frequency and experienced neck twitching during device programming at the visit.The patient¿s device was disabled and the patient was sent for x-rays.The patient underwent lead replacement surgery on (b)(6) 2014.The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits (impedance value ¿ 1323 ohms).The explanted lead has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative

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

Event Description

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 cut ends of the returned lead portions.

Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the fluid leaks found during product analysis.

Event Description

Analysis of the returned lead portion was completed which confirmed opening of the inner tubing, exposing conductive quadfilar coils.The openings may have been wear-related and may have contributed to the reported muscle spasms.Scanning electron microscopy images of the connector ring surface show that pitting or electro¿etching conditions have occurred on the surface.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Note that since the lead¿s electrodes were not returned for analysis, an evaluation cannot be made on that portion of the lead.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not observe any lead discontinuity.Lead discontinuity is suspected in the lead portion not returned, but did not cause or contribute to a death.Device failure occurred, but did not cause or contribute to death.

• 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: 4426437
• MDR Text Key: 5168440
• Report Number: 1644487-2015-03640
• 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,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2010
• Device Model Number: 302-30
• Device Lot Number: 200588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2007
• 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: 17 YR