BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 4150837 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16190
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE (LOC). THE LEAD WAS TESTED ON A PACING SYSTEM ANALYZER (PSA) AND REVEALED HIGH MEASUREMENTS IN THE 700 -1,100 OHMS RANGE AND LOC. THIS LEAD WAS SURGICALLY ABANDONED ON THE LEFT SIDE AND THE NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LOCATION OF THE BREAK WAS NOT CONCLUSIVELY DETERMINED AND LOC DID NOT RESULT IN ASYSTOLE GREATER THAN 2 SECONDS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633079 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N161

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 1861| 4543| 0147| N161| 5076| 4470| 0185| T165