BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR DR

    MDR report key: 3925690 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15605
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 7, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION DUE TO A HIGH CURRENT DRAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION AND A LEAD IMPEDANCE MEASUREMENT ANOMALY. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404857 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention