BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLUS

    MDR report key: 3926074 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15408
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND INSULATION ABRASION EXPOSING THE OUTER COIL CONSISTENT WITH ABRASION CAUSED BY FRICTION TO ANOTHER IMPLANTABLE DEVICE AT 24.6 CM TO 25.5 CM FROM THE CONNECTOR PIN. (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
    403331 PASSIVE PLUS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1246T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1