BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 3923888 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14818
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960013
    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 WAS RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT ONLY A PARTIAL LEAD WAS RETURNED. INSULATION DEGRADATION WAS NOTED AT 4.4. CM FROM THE CONNECTOR PIN. RELIABILITY LABORATORY TECHNICIAN. (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
    402071 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1999/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1