BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR DR

    MDR report key: 3920516 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14111
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 15, 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
    CA
    Reporter Occupation
    PHYSICIAN

    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 DURING AN ELECTIVE UPGRADE FOR A PACER DEPENDENT PATIENT, THE PULSE GENERATOR WENT INTO BACKUP VVI MODE. ELECTROCAUTERY INTERACTION WAS SUSPECTED, AND THE DEVICE ALSO EXHIBITED LOSS OF PACING OUTPUT. THE PATIENT EXPERIENCED ASYSTOLE WHEN THE DEVICE WAS TAKEN OUT OF POCKET. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396553 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention