BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950442 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22503
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT RESOLUTION HAS BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE SHOCK VECTOR WAS REPROGRAMMED WHICH RESULTED IN NORMAL SHOCK IMPEDANCES. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED OUT OF RANGE SHOCK IMPEDANCES THROUGH THIS DEFIBRILLATION LEAD. IT WAS ALSO REPORTED THAT THE PATIENT RECENTLY RECEIVED SHOCKS TO CONVERT ATRIAL FIBRILLATION WITH SHOCK IMPEDANCES OF 71 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR 1298| 4469| 4471| 4518| 0185| N118