BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S,

    MDR report key: 1896275 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04934
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE PHYSICIAN ELECTED NOT TO REPLACE THE LEAD, AS THE PATIENT ATRIAL PACED ONLY A SMALL PERCENTAGE OF THE TIME. THE LEAD WOULD BE MONITORED AT REGULARLY SCHEDULED FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX S, PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1642T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR