BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL ST

    MDR report key: 3260254 · Received August 1, 2013

    Report

    Report Number
    2017865-2013-05042
    Event Type
    Death
    Date Received
    August 1, 2013
    Date of Event
    January 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ONLY THE CONNECTOR END WITH A LENGTH OF 7.1 CM WAS RECEIVED FOR ANALYSIS. ELECTRICAL TEST THAT COULD BE PERFORMED ON THE PARTIAL LEAD DID NOT FIND ANY SHORTS OR DISCONTINUITIES ON ANY CONDUCTION PATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE PATIENT WAS IN A LONG TERM CARE FACILITY. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360826 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death (B)(4)