BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX P

    MDR report key: 3926303 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15602
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ATRIAL LEAD EXHIBITED UNDERSENSING. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINED IMPLANTED. THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405220 ISOFLEX P PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1648T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR