BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1896701 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05181
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 24, 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 PROXIMAL INSULATION WAS ABRADED AT 38.4 CM FROM THE CONNECTOR PIN IN THE AREA WERE THE SUTURE SLEEVE WAS TIGHTENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS DISLODGED. THE LEADS WERE 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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4)