BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771509 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12714
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AFTER THE IMPLANT PROCEDURE OF THIS RIGHT VENTRICULAR (RV) LEAD, THE PHYSICIAN USED CONTRAST AND NOTED A DISSECTION INTO THE PERICARDIAL SPACE. THE PATIENT WAS SENT TO THE OPERATING ROOM TO HAVE IT DRAINED. THE PHYSICIAN INDICATED HE BELIEVED THE WIRE CAUSED IT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention