BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223573 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10236
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 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

    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 A LEAD REVISION WAS DONE ON THE RIGHT VENTRICULAR (RV) LEAD. X-RAY SHOWED RV LEAD HAD DISPLACED DURING POST IMPLANT CHECKUP. DECREASED ON RV R-WAVE WAS NOTED FROM 15 MV TO 3 MV, IT WAS ALSO NOTED THAT THE IMPEDANCE DROPPED HOWEVER STILL IN THE NORMAL RANGE AND NO RV CAPTURE AT MAXIMUM OUTPUT. THIS LEAD WAS SUCCESSFULLY REPOSITIONED WITH GOOD MEASURED LEAD PARAMETERS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323520 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R