BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3924053 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14976
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 17, 2013
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE ATRIAL LEAD, PERICARDIAL EFFUSION HAD OCCURRED. THE PATIENT WAS STABLE AND NO INTERVENTION WAS NECESSARY. THE LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400607 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other