BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3900860 · Received June 27, 2014

    Report

    Report Number
    2017865-2014-13973
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    November 20, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD INSULATION WAS CRUSHED AND ABRADED. THE PATIENT WAS DEPENDENT. DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE LEAD WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376808 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688 NA

    Patients

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