BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1073563 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02003
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS AND ALL MEASURED VALUES WERE WITHIN PRODUCT SPECIFICATIONS. VISUAL INSPECTION FOUND AN INSULATION ABRASION 53.4 CM FROM THE CONNECTOR PIN, CAUSED BY FRICTION TO ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN AV NODAL ABLATION. DURING THE ABLATION, LOSS OF VENTRICULAR CAPTURE WAS OBSERVED. A NEW PULSE GENERATOR WAS IMPLANTED, AND CAPTURE AND SENSING WERE NORMAL. SHORTLY AFTER IMPLANT OF THE NEW PACEMAKER, LOSS OF VENTRICULAR CAPTURE WAS AGAIN NOTED. THE PHYSICIAN ELECTED TO REPLACE THE VENTRICULAR LEAD.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention