BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EN TRUST

    MDR report key: 1250003 · Received October 1, 2008

    Report

    Report Number
    1250003
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    January 29, 2007
    Report Date
    March 5, 2007
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME IN TO HAVE DEVICE INTERROGATED AND WERE UNABLE TO INTERROGATE. PATIENT HAD SEVERE JUNCTIONAL BRADYCARDIA AND WAS NOT BEING PACED. PACING WIRES EXPERIENCED INCREASED THRESHOLDS BUT WERE ALREADY PROGRAMMED TO THE MAXIMUM OUTPUT. PATIENT WAS SYMPTOMATIC, TIRED, LISTLESS, DIZZY AND VOMITING. TWO DAYS LATER DEVICE WAS EXPLANTED AND REPLACEMENT ICD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EN TRUST ICD LWS MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT D154ATG *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR