BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE

    MDR report key: 3994716 · Received August 8, 2014

    Report

    Report Number
    2124215-2014-15224
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    LWS
    PMA / PMN Number
    P940008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING WHICH RESULTED IN 2-3 SECONDS OF PACING INHIBITION. HOWEVER, THE PATIENT MAINTAINED AN UNDERLYING RHYTHM OF 50 BEATS PER MINUTE (BPM). THE PATIENT IS PACER DEPENDENT BUT IT WAS CONFIRMED THAT NO ASYSTOLE GREATER THAN 2 SECONDS OCCURRED. ALL OTHER MEASUREMENTS WERE NORMAL. A SURGICAL INTERVENTION WAS PERFORMED WHERE THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466718 INTERVENE IMPLANTABLE LEAD LWS GUIDANT ANGLETON/ST. PAUL 497-24

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR T180| A135| 497-24| 1831| 438-10