BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1896194 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05157
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 5, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS BROKEN INSIDE DUE TO TOO MANY HELIX EXTENSIONS AND RETRACTIONS AT IMPLANT. THE PHYSICIAN FELT THAT THE BIPOLAR LEAD IMPEDANCE WAS TOO HIGH (1700 OHMS). AS THE LEAD WAS SOLIDLY SCREWED INTO THE RIGHT VENTRICLE, THE PHYSICIAN CLOSED THE POCKET WITHOUT CONNECTING A PULSE GENERATOR AND SENT THE PATIENT TO ANOTHER MORE EXPERIENCED FACILITY. THE FOLLOWING DAY, THE LEAD WAS CAPPED 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 77 YR Required Intervention