BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911929 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16608
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 WAS SURGICALLY ABANDONED DURING THE RECENT DEVICE CHANGE OUT PROCEDURE. THE LEADS PACING IMPEDANCES HAD RISEN FROM 500 OHMS TO GREATER THAN 1500 OHMS FROM ONE MEASUREMENT TO THE NEXT. THE LEAD WAS SUCCESSFULLY REPLACED WITHOUT INCIDENT. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16459 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0157| 0292| 5554| 1861| E142| T125