BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 1223913 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03387
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 16, 2008
    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
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS WERE COVERED IN A DIRTY DARK YELLOW SUBSTANCE, DUE TO AN ALLERGIC REACTION. THE INSULATION WAS SEVERELY DEGRADED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF HER BODY REJECTING IMPLANTS. THE ENTIRE SYSTEM 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 Required Intervention