BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211275 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08256
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    July 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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    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 RECEIVED INDICATES THAT THERE WERE ADDITIONAL INSTANCES OF THE LOW, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW, OUT-OF-RANGE PACING IMPEDANCES WHICH WAS IDENTIFIED BY A REMOTE MONITORING ALERT. ACCORDING TO THE LOCAL REPRESENTATIVE, THE IMPEDANCES HAVE BEEN STABLE RANGING FROM 222-279 WITH THE EXCEPTION OF THIS ONE MEASUREMENT WHICH WAS <200 OHMS. THE PATIENT WILL BE MONITORED AND NO INTERVENTION IS PLANNED AT THIS TIME. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311296 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0176

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4470| 0176| N118| 4518