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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
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.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
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 Key4426437
Report Number1644487-2015-03640
Device Sequence Number1
Product CodeLYJ
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
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2010
Device MODEL Number302-30
Device LOT Number200588
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/06/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/17/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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