BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2013898 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01576
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    November 30, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS DAMAGED AND ABRADED, THE PROXIMAL COIL WAS FRACTURED AND THE DISTAL COIL BENT AT 9.0 CM FROM THE CONNECTOR PIN. THE LOCATION AND MODE OF THE DAMAGED INDICATES THAT THE LEAD WAS ABRADED AGAINST ANOTHER IMPLANTABLE DEVICE AND THE PROXIMAL COIL FRACTURED DUE TO FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED A SUDDEN IMPEDANCE INCREASE TO 1300 OHMS. A THRESHOLD INCREASE WAS ALSO NOTED. AN INSULATION DEFECT WAS SUSPECTED. THE LEAD WAS EXPLANTED 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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention