BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3924202 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15128
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 28, 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. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND INSULATION ABRASION AT 39.2CM TO 39.4CM FROM THE CONNECTOR PIN. THE ABRASION WAS CONSISTENT WITH CONSTANT FRICTION TO ANOTHER IMPLANTABLE DEVICE. (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
    399745 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1688T/100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1