BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 3875087 · Received June 16, 2014

    Report

    Report Number
    2017865-2014-13845
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    April 5, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENT'S CAUSE OF DEATH WAS ACUTE RESPIRATORY FAILURE AND SEPTIC SHOCK.

    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
    352071 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death 2088TC/52,CAU147770PM2210, 7445057