BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2920891 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01350
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    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 PATIENT WAS TOLD BY AN UNKNOWN INDIVIDUAL THAT THEIR RIGHT VENTRICULAR (RV) LEAD WAS NOT PERFORMING PROPERLY AND THAT THEY MIGHT HAVE TO CONSIDER RE-IMPLANTING IT AGAIN. UPON CLARIFICATION, THE PATIENT WAS UNSURE IF THIS PERFORMANCE ISSUE WAS ACTUALLY RELATED TO THEIR RV LEAD OR THEIR IMPLANTED PACEMAKER. THE PATIENT DID NOT SEEM TO FULLY UNDERSTAND OR HAVE CLEAR DETAILS ABOUT THIS PARTICULAR PRODUCT PERFORMANCE ISSUE AND THEY WERE ADVISED TO CONTACT THEIR CARDIOLOGIST TO FURTHER DISCUSS THEIR CONCERNS AND QUESTIONS. NO FURTHER ADDITIONAL INFORMATION ABOUT THIS EVENT WAS MADE AVAILABLE BY A COMPANY REPRESENTATIVE. AS OF TODAY, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26142 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR E102| MISMATCH| 0185