BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 3884347 · Received June 19, 2014

    Report

    Report Number
    2017865-2014-13857
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    May 21, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOURS AFTER THE IMPLANT PROCEDURE, THE PATIENT WAS TREATED FOR A PERICARDIOCENTESIS AS A RESULT OF AN EFFUSION OF BLOOD IN THE PERICARDIAL SACK. THE PATIENT WAS STABILIZED AND WAS OK. THE PATIENT DECEASED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359770 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death 2088TC/46 CNX017036