BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONTIER II

    MDR report key: 4073632 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16678
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    July 25, 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
    CA, 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 THE PULSE GENERATOR EXHIBITED A DIAGNOSTICS ANOMALY. NO INTERVENTION HAD BEEN REPORTED. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553921 FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR NKE ST. JUDE MEDICAL, INC., CRMD 5586 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR