BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX LEAD

    MDR report key: 4192061 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04657
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 28, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960030
    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. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE COMPLAINT COULD BE VERIFIED. INSULATION DAMAGE WAS NOTED ON THE OUTER INSULATION AT 8 CM FROM THE CONNECTOR PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN REMOVED THE LEAD FROM THE BOX AND INSULATION DAMAGE WAS IMMEDIATELY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27883 ISOFLEX LEAD PERMANENT ELECTRODE, DTB DTB ST. JUDE MEDICAL, CRMD 1944/52

    Patients

    Seq Age Sex Outcome Treatment
    1