BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX

    MDR report key: 3894418 · Received June 25, 2014

    Report

    Report Number
    2017865-2014-13966
    Event Type
    Death
    Date Received
    June 25, 2014
    Date of Event
    April 24, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE CAUSE OF DEATH WAS ACUTE RESPIRATORY FAILURE AND BLADDER CANCER. THE DEATH WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370873 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death (B)(4)