BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL ST

    MDR report key: 4243515 · Received November 11, 2014

    Report

    Report Number
    2017865-2014-19324
    Event Type
    Death
    Date Received
    November 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726839 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 5816,1264876, 1488TC,BU10287