BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853530 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14934
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE PROCEDURE TO IMPLANT THIS TRANSVENOUS DEFIBRILLATION LEAD, THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND LOW BLOOD PRESSURE. A CHEST X-RAY AND ECHOCARDIOGRAM WERE PERFORMED AND NOTED A LEAD PERFORATION NEAR THE TRICUSPID VALVE. IT WAS NOTED THAT AN EMERGENCY STERNOTOMY WAS DONE, AND THE INJURY WAS SUTURED. IT WAS LATER NOTED THAT THE PATIENT WOULD BE IMPLANTED WITH A PACEMAKER UNTIL THEY CAN BE IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THAT THE PERFORATION WAS THOUGHT TO BE DUE TO THE PHYSICIAN, THE PATIENT'S DISEASED HEART, AND THE FRACTURED NON-BOSTON SCIENTIFIC LEAD. THE PATIENT WAS NOTED TO BE ALIVE AND IN STABLE CONDITION. THIS LEAD WAS REMOVED FROM THE PATIENT AND THE LOCATION OF THE LEAD IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening 4047| 7288| 5076| 6949| 0185