BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1073273 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02072
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 27, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AND THE COILS WERE CRUSHED AT 27 CM FROM THE CONNECTOR PIN. THE DISTAL INSULATION WAS DAMAGED IN THE SAME AREA, WHICH COULD OF CAUSE THE SHORT BETWEEN COILS DUE TO CLAVICULAR CRUSH.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS ALSO NOTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED AT THE TIME OF EXPLANT. EXPLANT WAS FOR ELECTIVE REPLACEMENT INDICATOR (ERI).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE IN BIPOLAR AND ABOUT 242 OHMS IMPEDANCE IN THE UNIPOLAR CONFIGURATION DUE TO CLAVICULAR CRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1788TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention