BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911406 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16601
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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 DURING A RECENT INTERROGATION, THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) NOTED THAT THERE WAS A CHECK LEAD STATUS MESSAGE DISPLAYED. THE PATIENT HAD A RECENT VENTRICULAR EPISODE THAT WAS TREATED WITH ANTI-TACHYCARDIA PACING (ATP) THEN ESCALATED INTO THE VENTRICULAR FIBRILLATION (VF) ZONE AND A SHOCK WAS GIVEN. THE SR WAS QUESTIONING THE CHECK LEAD MESSAGE AND ITS POSSIBLE CORRELATION TO THE EPISODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT THIS COULD BE FOR EITHER HIGH OR LOW OUT OF RANGE IMPEDANCES, AND WITHOUT THE PATIENT THERE TO CHECK, IT WAS IMPOSSIBLE TO TELL WHICH MEASUREMENT IT WAS FOR. TS SUGGESTED AT THE NEXT CHECK, THEY SHOULD TEST THE LEADS MAKE SURE THERE IS NO NOISE PRESENT AND FOR NOW, CONTINUE TO MONITOR THE LEAD. THE LEAD AND DEVICE REMAIN IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17368 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0185| E102| T135