BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954023 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24205
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED APPROPRIATELY AND THIS LEAD REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANTATION OF THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD, THE PATIENT REPORTED NOT FEELING WELL. IT WAS DISCOVERED THAT THIS LEAD HAD PERFORATED THE HEART WALL IN TWO PLACES, RESULTING IN A TAMPONADE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R