BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954076 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23864
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, A REVISION PROCEDURE TOOK PLACE. IT WAS NOTED THAT THE RV LEAD POSSIBLY EXPERIENCED A SUB-CLAVIAN CRUSH CAUSING HIGH SHOCKING IMPEDANCES TO BE RECORDED. THE RV LEAD WAS CAPPED AND BURIED AND REPLACED. A NEW DEVICE WAS ALSO IMPLANTED. THE EXPLANTED ICD WILL BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE SYSTEM REMAINS IMPLANTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A PHONE CALL THAT DURING A FOLLOW UP OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MEASUREMENTS OF LOW SHOCKING IMPEDANCES AND HIGH SHOCKING IMPEDANCES WERE NOTED. THE DEVICE ALSO TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE CUSTOMER WANTED TO KNOW IF OUT OF RANGE SHOCKING IMPEDANCES WERE THE RESULT OF THE DEVICE TRIGGERING ERI. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES DISCUSSED THAT IT APPEARS THAT THERE IS NO ISSUES WITH THE DEVICE AND SUGGESTED CHECKING THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY BEFORE IMPLANTING A NEW DEVICE. A POSSIBLE ISSUE WITH THE LEADS WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1