BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1223807 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03211
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE LEAD OUTER INSULATION WAS ABRADED AT 5 CM FROM THE DISTAL TIP ELECTRODE. THIS COULD BE CAUSED BY FRICTION TO ANOTHER DEVICE AND AS A RESULT, CAPTURE ANOMALIES COULD OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE THRESHOLDS HAD RISEN TOO HIGH IN A SHORT AMOUNT OF TIME AND DECIDED TO TO REPLACE THE LEAD. LOW IMPEDANCE WAS ALSO NOTED. DURING THE EXTRACTION, IT WAS NOTED THAT THE LEAD HAD INSULATION ABRASION AND DEGRADATION AT ABOUT THREE INCHES FROM THE DIS- TAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention