BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2933105 · Received January 29, 2013

    Report

    Report Number
    1644487-2013-00229
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICEREVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED HIGH LEAD IMPEDANCE WITH VNS SYSTEMS AND NORMAL MODEL DIAGNOSTICS WERE RECEIVED FOR A PATIENT AT AN OFFICE VISIT. THE VNS WAS DISABLED. VNS DIAGNOSTICS WERE LAST WITHIN NORMAL LIMITS IN (B)(6) 2012. NO TRAUMA OR DEVICE MANIPULATION OCCURRED. VNS LEAD AND GENERATOR REPLACEMENT SURGERY OCCURRED ON (B)(6) 2013. DURING THE SURGERY, FIBROSIS WAS NOTED AT THE ELECTRODE SITE AND THE ELECTRODES WERE UNABLE TO BE COMPLETELY REMOVED. DIAGNOSTICS WITH THE NEW VNS LEAD AND GENERATOR WERE WITHIN NORMAL LIMITS. ATTEMPTS FOR RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.

    Description of Event or Problem · 1

    X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER ON (B)(6) 2013. A FRANK LEAD BREAK IS NOTED AT THE TOP OF THE FIRST LEAD STRAIN RELIEF BEND. THE LEAD PIN APPEARS FULLY INSERTED INTO THE GENERATOR HEADER. THE LEAD WIRE IS INTACT AT THE LEAD PIN. THERE IS A SMALL AMOUNT OF LEAD BEHIND THE GENERATOR THAT CANNOT BE ASSESSED. THE CAUSE OF THE HIGH LEAD IMPEDANCE IS DUE TO THE FRANK BREAK NOTED ON THE FIRST STRAIN RELIEF BEND NEAR THE ELECTRODE AREA.ALL ATTEMPTS FOR RETURN OF THE EXPLANTED LEAD AND GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39442 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1061

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR