BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911459 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16136
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    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 SHORTLY AFTER THE IMPLANT OF THIS RIGHT VENTRICULAR LEAD, A ROUTINE X RAY SHOWED A POSSIBLE SMALL LEAD PERFORATION. ADDITIONALLY, THE LEAD DISPLAYED DECREASED SENSING, DECREASED IMPEDANCES, AND LOSS OF CAPTURE DUE TO HIGH PACING THRESHOLDS. THE LEAD WAS REPOSITIONED SUCCESSFULLY WITH ADEQUATE LEAD DIAGNOSTICS. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17620 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R