BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153670 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06465
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 10, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA LATITUDE RED ALERT, THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW SHOCK IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS BROUGHT IN FOR EVALUATION AND THE EVERYTHING TESTED NORMAL; HOWEVER, A FULL ENERGY SHOCK WAS NOT PERFORMED. AT THIS TIME, THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR T165| 0185| 0180| E110| 4469| 4087