BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR DR

    MDR report key: 3920506 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14094
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR HAD ENTERED INTO BACKUP MODE AS A RESULT OF A CHECKSUM ERROR. FOLLOWING A FIRMWARE DOWNLOAD, NORMAL DEVICE CHARACTERISTICS WERE OBSERVED.

    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 BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396239 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention