BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212478 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09495
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 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

    AVAILABLE INFORMATION INDICATES THIS 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 PLACEMENT DIFFICULTY WAS ENCOUNTERED WHILE IMPLANTING THIS RIGHT VENTRICULAR (RV) LEAD. IT WAS FINALLY ABLE TO BE POSITIONED IN THE APEX. THE PHYSICIAN HAD GONE BACK TO REPOSITION THE LEFT VENTRICULAR (LV) LEAD WHEN THE PATIENT'S CONDITION DETERIORATED AND THE PATIENT BEGAN VOMITING. UNDER FLUOROSCOPY AND ECHOCARDIOGRAPHY, A PERFORATION WAS OBSERVED. THE LEAD WAS REPOSITIONED TO THE SEPTUM, WHERE ADEQUATE SENSING MEASUREMENTS WERE OBTAINED. THE LV LEAD WAS NOT REPOSITIONED AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314270 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R