BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6172167 · Received December 13, 2016

    Report

    Report Number
    2017865-2016-07804
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS. ON (B)(6) 2016 THE PATIENT EXPERIENCED CARDIAC TAMPONADE. ON (B)(6) 2016 AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED. ON (B)(6) 2016 THE PHYSICIAN SUCCESSFULLY REPOSITIONED THE LEAD AND ALL LEAD ELECTRICAL VALUES WERE IN RANGE. THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820751 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/52 P000032616

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention