BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3926095 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15436
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 NOISE, WHICH INITIATED AUTO MODE SWITCH EPISODES. THE NOISE COULD BE REPRODUCED WITH PROVOCATIVE MANEUVERS AND ARM ROTATIONS. THE DEVICE COULD NOT BE REPROGRAMMED DUE TO OVERSENSING MYOPOTENTIALS IN UNIPOLAR CONFIGURATION. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403383 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1