BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053223 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05103
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    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 LEAD REMAINS 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 DURING THE IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, THE VENTRICLE WAS PERFORATED. THE PATIENT WAS STABILIZED AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PACING THRESHOLDS WERE NOT MEASURED AGAIN THROUGH THE DEVICE AFTER THE PERFORATION WAS TREATED. THE DEVICE WAS PROGRAMMED WITH TACHY THERAPY OFF WHILE THE PATIENT WAS MONITORED IN THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155327 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R