BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONTIER II

    MDR report key: 3920452 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14053
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NKE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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 THE PULSE GENERATOR EXHIBITED A HIGH CURRENT DRAIN. NO INTERVENTION HAS BEEN REPORTED AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396453 FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR NKE ST. JUDE MEDICAL, INC., CRMD 5596 NA

    Patients

    Seq Age Sex Outcome Treatment
    1