BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041774 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01712
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE AND LEAD REMAINS IMPLANTED THUS NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD A TELEMETRY ISSUE WAS NOTED. MEASUREMENTS WERE THEN TAKEN WITH A PROGRAMMER WHICH SHOWED TO BE OUT OF RANGE ON THE SHOCKING AND PACING CHANNEL. THE ICD AND LEAD WERE RECONNECTED WHICH STILL SHOWED OUT OF RANGE IMPEDANCES, WHILE MEASUREMENTS TAKEN WITH A PACING SYSTEM ANALYZER (PSA) SHOWED NORMAL MEASUREMENTS. FINALLY THE PROGRAMMER WAS RESTARTED AND THE SYSTEM WAS INTERROGATED WHICH SHOWED NORMAL PACING AND SHOCKING IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 0296| F103