BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2013997 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01577
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    November 19, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 AT 11.5 CM FROM THE CONNECTOR PIN. THE DAMAGED INSULATION CREATED A SHORT BETWEEN THE COILS AND RESULTED IN THE REPORTED IMPEDANCE ANOMALY. THE DAMAGE IS CONSISTENT WITH MECHANICAL STRESS (I.E.: SUTURE SLEEVE TIE-DOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED LOW LEAD IMPEDANCE AND NOISE. THE LEAD WAS EXPLANTED.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention