BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954124 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24288
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 23, 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

    AT THIS TIME THE DEVICE AND RIGHT VENTRICULAR LEAD REMAIN IN SERVICE. EFFORTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE SALES REPRESENTATIVE CONFIRMED THE ISSUE WAS RESOLVED BY CHANGING THE LEAD CONFIGURATION TO DISTAL TO CAN WHICH RESULTED IN SATISFACTORY SHOCK IMPEDANCE MEASUREMENTS. NO FURTHER ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS DETECTED DUE TO HIGH SHOCK IMPEDANCE VALUES. THE REASON FOR THE OUT OF RANGE SHOCK IMPEDANCES WAS NOT PROVIDED. 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 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 0157| E110| 4469