BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212971 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10017
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 29, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    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 HIGH OUT-OF-RANGE (OOR) IMPEDANCE MEASUREMENT OF GREATER THAN 2500 OHMS. ADDITIONALLY, THERE WAS LOSS OF CAPTURE (LOC) AND NO SENSING. THE PATIENT REPORTED THAT THEY FELL DOWN AND HURT THEIR SHOULDER, AND IT IS BELIEVED TO HAVE FRACTURED THE LEAD. THE PHYSICIAN IS AWARE OF THIS AND CHOSE TO PROGRAM THE DEVICE TO AAIR AND MONITOR FOR NOW, TO AVOID ANY SURGERY. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED. A NEW RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314039 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4479| S606