BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223616 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-09983
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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 THIS RIGHT VENTRICULAR (RV) LEAD PERFORATED THE HEART WALL. IT WAS REPORTED THAT THE PATIENT HAD CHEST DISCOMFORT ALONG WITH LOW RV WAVES AND LOSS OF CAPTURE (LOC) AT HIGH OUTPUTS. A REVISION PROCEDURE WAS DONE TO REPOSITION THE LEAD. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324403 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4470| 0295| E162