BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2172883 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10036
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    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 LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT WILL BE SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK IMPEDANCES GREATER THAN 125 OHMS. THE PATIENT'S PHYSICIAN DID NOT FEEL THAT THE OUT OF RANGE MEASUREMENTS WERE DUE TO A CONNECTION ISSUE AS THE SHOCK IMPEDANCE MEASUREMENTS WERE HIGH AT IMPLANT AND WAS AWARE OF THE SITUATION; THE LEAD REMAINS IMPLANTED AT THIS TIME. THE PATIENT WILL BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 0181