BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX LEAD

    MDR report key: 1955841 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00998
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 5, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THE PROXIMAL INSULATION DAMAGED/MELTED CLOSE TO THE SUTURE SLEEVE LOCATION AT 17.3 CM FROM THE CONNECTOR PIN. THIS DAMAGE OCCURRED IN THE FIELD AND IS NOT A RESULT OF DEFICIENCY IN MATERIAL OR WORKMANSHIP. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED VARIABLE SENSING THRESHOLDS AND NOISE, LEADING TO MODE SWITCHES. THIS CAUSED LOSS OF AV SYNCHRONY, PACEMAKER SYNDROME AND PACEMAKER MEDIATED TACHYCARDIA EPISODES. SYMPTOMATIC EPISODES HAD INCREASED RECENTLY TO THE POINT OF HOSPITAL ADMISSION. THE PATIENT EXPERIENCED FATIGUE, PRESYNCOPE, SYNCOPE AND PALPITATIONS. THE LEAD WAS EXPLANTED AND REPLACED, AT WHICH TIME INSULATION DAMAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention