BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4073675 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16687
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    June 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 EXPLANT, A LOSS OF OUTPUT WAS OBSERVED ON THE PULSE GENERATOR WHEN ELECTROCAUTERY WAS USED. WHEN ELECTROCAUTERY WAS STOPPED, OUTPUT RESUMED. THE DEVICE WAS SUCCESSFULLY EXPLANTED. NO REPLACEMENT DEVICE WAS IMPLANTED DUE TO THE PATIENT BEING TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554330 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR