BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3923493 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14763
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 20, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS NOTED THAT ONLY THE CONNECTOR END OF THE LEAD WAS RECEIVED. INSULATION DEGRADATION WAS NOTED AT 4.5 CM FROM THE CONNECTOR PIN. (B)(4). (B)(6).

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399658 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1948/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1