BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043580 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02149
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 27, 2013
    Report Date
    February 7, 2013
    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

    TECHNICAL SERVICES WAS NOT ABLE TO PROVIDE ADDITIONAL INFORMATION WHEN REVIEWING THE PATIENT LATITUDE INFORMATION. AT THIS TIME THERE HAS BEEN NO CHANGE TO LEAD.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS DISCUSSED BY TECHNICAL SERVICES AND ADDITIONAL QUESTIONS WERE REQUIRED FOR A COMPLETE ANALYSIS OF THIS CASE. TECHNICAL SERVICES DISCUSSED POSSIBLE INDICATION FOR THIS CASE AS WELL AS TROUBLESHOOTING. ADDITIONAL INFORMATION FROM THE REP WAS PROVIDED WHICH NOTED THAT THE PACING IMPEDANCES WERE STABLE AT IMPLANT AND HAVE GRADUALLY INCREASED OVERTIME. IN ADDITION, THE PACING THRESHOLDS HAD ALSO INCREASED BUT IT WAS NOT POSSIBLE TO DETERMINE OF THIS CHANGE WAS ACUTE OR CHRONIC. THE SENSING AND SHOCKING IMPEDANCES WERE STABLE. TECHNICAL SERVICES DISCUSSED REVIEWING THE PATIENTS DATA IN LATITUDE TO FURTHER DETERMINE THE ROOT CAUSE OF THIS CASE. AT THIS TIME THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS TRIGGERED DUE TO OUT OF RANGE PACING IMPEDANCES ON THE RIGHT VENTRICULAR LEAD. AN INCREASE IN PACING THRESHOLDS WAS ALSO NOTED. REPROGRAMMING TOOK PLACE AND ANOTHER FOLLOW UP HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146595 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1