BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2792713 · Received October 16, 2012

    Report

    Report Number
    2124215-2012-14012
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 12, 2007
    Report Date
    September 28, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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 RIGHT VENTRICULAR (RV) LEAD PREVIOUSLY EXHIBITED INCREASED THRESHOLDS UP TO 2.7 VOLTS (V) AND DECREASED R-WAVES AS LOW AS 1.6M V. MOST RECENTLY THE LEAD DISPLAYED LOSS OF MYOCARDIAL CAPTURE AND NO SENSING. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS CAPPED. A NEW RV LEAD WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT PRIOR TO THE LEAD BEING REVISED, THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AFTER FEELING LIGHTHEADED. THE PATIENT'S RATE HAD DROPPED INTO THE 40'S FROM A LOWER RATE LIMIT OF 60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 1190| 4457