BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3924062 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14981
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE VENTRICULAR LEAD EXHIBITED NO SENSING. ANOTHER ATTEMPT TO IMPLANT THE LEAD WAS MADE, THE PATIENT WENT INTO COMPLETE HEART BLOCK AND REQUIRED EXTERNAL PACING. THE PATIENTS BLOOD PRESSURE DROPPED. THE LEAD WAS NOT IMPLANTED. LATER THAT DAY THE PATIENT DEVELOPED A CARDIAC TAMPONADE AND UNDERWENT A PERICARDIOCENTESIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399352 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention