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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 302-20
Event Date 08/11/2014
Event Type  Malfunction  
Event Description

Analysis of the returned lead portion was completed which confirmed discontinuity of negative quadfilar coil in the body region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Abraded openings were observed on both the outer and inner tubing near the break location. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils.

 
Manufacturer Narrative

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

 
Event Description

An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to near end of service and lead discontinuity. Follow-up revealed that the procedure was originally scheduled for only generator replacement due to near end of service. Diagnostic results showed lead impedance within normal limits prior to surgery and high impedance was first observed during the procedure. The surgeon elected the replace the patient¿s lead and stated that the explanted lead was kinked. The explanted generator and lead have not been returned to date.

 
Manufacturer Narrative

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

 
Event Description

The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.

 
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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 Key4077034
Report Number1644487-2014-02291
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/11/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number302-20
Device LOT Number201126
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/17/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/18/2009
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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