BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 1896370 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05348
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 20, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED AN INAPPROPRIATE LONGEVITY ESTIMATE. MEASURED DATA VALUES WERE 2.78 V, 10 UA AND LESS THAN 1 KOHMS, WITH AN ESTIMATED REMAINING LONGEVITY OF 2 YEARS. THE ESTIMATE GIVEN BY TECHNICAL SERVICES WAS 5-7.1 YEARS REMAINING LONGEVITY AT 100 PERCENT PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR