BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4151242 · Received October 8, 2014

    Report

    Report Number
    1644487-2014-02575
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED AND SYSTEM DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE (DC DC ¿ 7). THE DEVICE WAS SUBSEQUENTLY DISABLED. THE PATIENT WAS SUSPECTED TO HAVE BEEN MANIPULATING HIS DEVICE AND WAS EXPERIENCING AN INCREASE IN SEIZURES. FOLLOW-UP REVEALED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO BATTERY DEPLETION, THE PATIENT¿S LEAD APPEARED TO BE ¿WORN OUT¿. DIAGNOSTIC RESULTS WITH THE REPLACEMENT GENERATOR AND EXISTING LEAD SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS DURING THE PROCEDURE. X-RAYS WERE REPORTED BY THE PHYSICIAN TO BE UNREMARKABLE AND PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LOWER LEFT CHEST IN ABNORMAL PLACEMENT. THE LEAD CONNECTOR PIN APPEARS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. DUE TO THE QUALITY OF THE IMAGES PROVIDED, NO FURTHER OBSERVATIONS COULD BE MADE AND THE CAUSE OF THE HIGH LEAD IMPEDANCE REMAINS UNKNOWN. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT LEAD REPLACEMENT SURGERY DUE TO LEAD DISCONTINUITY. THE LEAD IMPEDANCE WITH THE NEW LEAD ATTACHED TO THE EXISTING GENERATOR WAS WITHIN NORMAL LIMITS. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632856 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1898

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention