BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1955787 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00847
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    April 12, 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 THE PROXIMAL INSULATION ABRADED AND THE SENSING COIL EXPOSED BETWEEN 14.1 CM AND 14.3 CM FROM THE CONNECTOR PIN, MOST LIKELY DUE TO FRICTION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAN. IN THE DAMAGED AREA ONE FILAR WAS FRACTURED AND MELTED AND SEVERAL AROUND IT WERE PARTLY MELTED. THE ENERGY FROM THE SHOCK THE ICD DELIVERED MOST LIKELY TRANSFERRED TO THE DAMAGED AREA, CAUSING THE FILARS TO MELT. THE LEAD ABRASION TOWARDS THE CAN COULD CAUSE OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED TO THE HOSPITAL AFTER RECEIVING SHOCKS WHILE CARRYING A SHOPPING BAG. THE RIGHT ATRIAL LEAD EXHIBITED ARTIFACTS ON THE INTRACARDIAC ELECTROGRAM. LATER THERE WAS NO ATRIAL SIGNAL OBSERVED AT ALL. THE RING OF THE LEAD WAS FOUND TO BE -DEFECTIVE-. 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 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)