BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780211 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13255
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD. THE PATIENT'S FOLLOWING CLINIC CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND DISCUSSED THAT THIS RV LEAD HAS SHOWN INCREASES IN PACING IMPEDANCE OVER THE LAST YEAR, AND APPROXIMATELY TWO MONTHS AGO IMPEDANCE MEASUREMENTS EXCEEDED 2000 OHMS. ASSOCIATED NOISE ON THE LEAD WAS ALSO NOTED, HOWEVER, NO PACING INHIBITION OR INAPPROPRIATE SHOCKS WERE REPORTED. THE PATIENT UNDERWENT SURGICAL INTERVENTION AND WAS UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM AND THIS RV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R T175| 0175