BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210272 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08402
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT THEY PATIENT WAS BROUGHT IN FOR EVALUATION. NO ACTION AT THIS TIME WILL BE TAKEN, BUT WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND SINGLE COIL RIGHT VENTRICULAR (RV) LEAD WERE EXHIBITING HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED BRINGING THE PATIENT IN FOR ADDITIONAL TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310107 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 0292| E140