BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2173249 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10767
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD SAFETY SWITCH. VARYING IMPEDANCES, NOISE, OVERSENSING AND PACING INHIBITION OF 3 SECONDS WERE OBSERVED. THE ISSUES WERE UNABLE TO BE REPRODUCED WITH PATIENT ISOMETRICS, VALSALVA, OR IN UNIPOLAR OR BIPOLAR CONFIGURATIONS. IT WAS NOTED THAT THE LEAD WAS LEFT IN UNIPOLAR CONFIGURATION AND THIS WILL BE ADDRESSED AGAIN DURING THE PATIENT'S NEXT FOLLOW-UP VISIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 1270| S606| 4480| 4459