BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042289 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01275
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 9, 2012
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    ADDITIONAL INFORMATION WAS PROVIDED THAT HIGH RV IMPEDANCES WERE AGAIN DETECTED BY THE REMOTE MONITORING SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND THEY DISCUSSED THAT THE IMPEDANCE MEASUREMENTS WERE VARIABLE, BUT SENSING MEASUREMENTS WERE STABLE, AND THERE WAS NO NOISE OR OVERSENSING NOTED. TS PROVIDED OPTIONS OF BRINGING THE PATIENT IN FOR TESTING OR CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS TRANSVENOUS DEFIBRILLATION LEAD DUE TO HIGH RIGHT VENTRICULAR (RV) PACING IMPEDANCES. THE ALERT WAS DELIVERED TO THE PATIENT'S CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DAILY IMPEDANCE MEASUREMENTS WERE REVIEWED WITH THE PATIENT'S CLINIC, AND THIS PATIENT WAS NOTED TO HAVE A HIGH, BUT WITHIN RANGE, RV IMPEDANCE. IT WAS NOTED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)