BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3212947 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10352
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DURING A DEVICE REPLACEMENT PROCEDURE. A NEW RV LEAD WAS IMPLANTED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD SAFETY SWITCH DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PATIENT INDICATED THEY HAD BEEN HAVING SOME LIGHTHEADEDNESS BUT UNSURE IF IT IS RELATED. THE FIELD REPRESENTATIVE WILL BE DISCUSSING PROGRAMMING WITH THE PHYSICIAN. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT HE BELIEVES A REVISION PROCEDURE HAS BEEN SCHEDULED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312371 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR 4469| 4470| 1290