BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212658 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09650
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    December 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED ONE HIGH OUT-OF-RANGE (OOR) IMPEDANCE MEASUREMENT OF 128 OHMS WHICH WAS UP FROM 90 OHMS MEASURED PREVIOUSLY AT IMPLANT. THERE WERE NO OTHER OUT OF RANGE MEASUREMENTS, AND THE PHYSICIAN PLANS TO MONITOR THE LEAD FOR NOW. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS PATIENT CONTINUED TO HAVE OUT-OF-RANGE (OOR) IMPEDANCE MEASUREMENTS AND THE PHYSICIAN ELECTED TO DO DEFIBRILLATION THRESHOLD (DFT) TESTING TO ACCESS LEAD VIABILITY. AFTER TESTING THE IMPEDANCES WERE STILL RELATIVELY HIGH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT THE HOME MONITORING SYSTEM MIGHT CONTINUE TO DETECT THESE OOR MEASUREMENTS SINCE THEY WERE STILL HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314210 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR E140| 0292