BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL SR

    MDR report key: 1222920 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03270
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 5, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMAP880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE DEVICE COULD NOT BE INTERROGATED AS RECEIVED, DUE TO A CORRUPTED ID BIT. REVIEW OF THE DEVICE IMAGE FOUND MULTIPLE BITS FLIPPED. WHEN THE CORRECT ID BIT WAS PROGRAMMED, THE PACEMAKER COULD BE INTERROGATED, AND WAS FOUND IN BACKUP VVI MODE. DEVICE SOFTWARE WAS DOWN- LOADED, AND ANALYSIS FOUND HIGH CURRENT DRAIN AND LOW BATTERY VOLTAGE. ONE HOUR AFTER A RESET WAS PERFORMED, NORMAL FUNCTION ENSUED. THE PULSE GENERATOR WAS MONITORED FOR A MONTH AND THE HIGH CURRENT DRAIN DID NOT RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5620 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention