BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 4231312 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18106
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 22, 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 WAS RECEIVED WITH THE RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED. AN INSULATION DEGRADATION WAS NOTED AT 4.5 CM FROM THE CONNECTOR PIN. (B)(6). (B)(4).

    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
    715489 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1948/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1