BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 3920480 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14087
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NEAR SYNCOPAL EVENT WHEN PRESENTED FOR A FOLLOW-UP. UPON INTERROGATION, THEIR PULSE GENERATOR WAS FOUND IN BACKUP MODE. THE DEVICE COULD NOT BE RESTORED DUE TO LOW BATTERY VOLTAGE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396824 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention