BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPATH

    MDR report key: 1771549 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12896
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    August 25, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NHW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT DAILY MEASUREMENTS WERE TURNED OFF ON THIS LEAD AND THAT LATITUDE COULD NOT SEND AN ALERT AS NO INFORMATION WAS GATHERED FROM THIS LEAD. THE LEAD AND DEVICE ARE SCHEDULED TO BE REPLACED IN THE NEAR FUTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND THE LEAD WAS SURGICALLY ABANDONED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT CAPTURE ON THIS LEFT VENTRICULAR LEAD. IMPEDANCES WERE > 2000 OHMS ON THIS LEAD. THERE WAS INQUIRY AS WHY A LATITUDE ALERT WAS NOT SENT. THE PATIENT HAD NOT BEEN FEELING WELL AND COMPLAINED OF SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPATH IMPLANTABLE LEAD NHW EXTERNAL MANUFACTURER 4046

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention H210| 4136| 4046| 0185| 4554