BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL ST

    MDR report key: 4953105 · Received July 30, 2015

    Report

    Report Number
    2017865-2015-27289
    Event Type
    Death
    Date Received
    July 30, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR HOURS AFTER A SUCCESSFUL IMPLANT PROCEDURE, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION. THE PHYSICIAN PERFORMED RESUSCITATION EFFORTS BUT THE PATIENT DECEASED. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496376 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1888TC/52 4760095

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death (B)(4)| 1888TC/52, (B)(4)