BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL SR

    MDR report key: 1073229 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02043
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    June 13, 2008
    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
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE MEASURED BATTERY DATA VALUES FOR THE BATTERY VOLTAGE WAS 2.23 V AND 2.27 V WHICH COULD CAUSE THE ELECTIVE REPLACEMENT INDICATOR (ERI) TO TRIP. AFTER THE ERI FLAG WAS CLEARED, NORMAL FUNCTION ENSUED. THE DEVICE WAS MONITORED AT ROOM TEMPERATURE OVER A PERIOD OF TIME WITHOUT REPRODUCING THE ANOMALY. NO EXPLANATION WAS FOUND FOR THE REPORTED MEASURED DATA ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD VARYING BATTERY CELL VOLTAGE READINGS AND AN ELECTIVE REPLACEMENT INDICATOR (ERI) TRIP. BATTERY VOLTAGE WAS 2.81 V AND AN ERI ALERT WAS PRES- ENT. ERI ALERT WAS CLEARED AND BATTERY DATA UPDATED, AND BATTERY VOLTAGE WAS 2.27 V. THE PATIENT WAS PACER DEPENDENT SO SHE WAS SENT TO THE EMERGENCY ROOM WHERE A SOFTWARE DOWN- LOAD WAS SUCCESSFULLY PERFORMED. POST DOWNLOAD, BATTERY VOLTAGE WAS 2.58 V. THE PATIENT IS TO BE CLOSELY MONITORED.

    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 5626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention