BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1955569 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00979
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    September 21, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE DISTAL INSULATION WAS DAMAGED WHICH RESULTED IN AN ELECTRICAL SHORT CIRCUIT BETWEEN THE COILS AND CAUSED THE REPORTED THRESHOLD AND LEAD IMPEDANCE ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE IN STIMULATION THRESHOLDS SINCE IMPLANT AND THE LEAD DID NOT CAPTURE AT MAXIMUM OUTPUT AND PULSE WIDTH. ATTEMPTS TO REPOSITION THE LEAD RESULTED IN A THRESHOLD OF 4.0 V IN THE UNIPOLAR AND GREATER THAN 7.0 V IN THE BIPOLAR CONFIGURATIONS. BIPOLAR IMPEDANCE WAS LESS THAN 200 OHMS. THE LEAD WAS REMOVED AND REPLACED.

    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 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention