BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212556 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09364
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    October 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WAS IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS IN THE HOSPITAL FOR NON DEVICE RELATED REASONS. THE FIELD REPRESENTATIVE WAS CALLED TO CHECK THE DEVICE BECAUSE INTERMITTENT LOSS OF CAPTURE (LOC) WAS NOTED. THE FIELD REPRESENTATIVE CHECKED THE DEVICE AND FOUND A LEAD SAFETY SWITCH HAD OCCURRED DUE TO HIGH OUT OF RANGE PACING IMPEDANCES. THE FIELD REPRESENTATIVE INDICATED A REVISION WOULD BE PERFORMED AS THIS RIGHT VENTRICULAR (RV) LEAD IS MOST LIKELY FRACTURED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313902 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4456| S603| 4135