BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1871146 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17526
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    FOURTEEN DAYS LATER THE LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE. IT WAS NOTED THAT THE PATIENT HAD TWIDDLER'S SYNDROME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT COMPLAINED OF NOT FEELING WELL AND BEING MORE TIRED THAN USUAL. UPON INTERROGATION, IT WAS NOTED THAT THE SAFETY SWITCH HAD TRIPPED FOR THE RIGHT ATRIAL (RA) LEAD DUE TO IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 2500 OHMS. WHEN THE LEAD WAS PROGRAMMED TO UNIPOLAR PACING, FARFIELD OVERSENSING WAS NOTED. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE PROGRAMMED THE LEAD BACK TO BIPOLAR PACING AND THE IMPEDANCE MEASUREMENTS STABILIZED TO APPROXIMATELY 530 OHMS; HOWEVER WHEN PERFORMING ISOMETRICS, NOISE WAS ABLE TO BE RECREATED AND THE IMPEDANCE MEASUREMENT RETURNED TO GREATER THAN 2500 OHMS. A LEAD FRACTURE IS SUSPECTED. A LEAD REVISION PROCEDURE WILL BE SCHEDULED IN THE FUTURE, AT THIS TIME THE RA LEAD WAS LEFT PROGRAMMED IN UNIPOLAR FOR PACING AND BIPOLAR FOR SENSING AND THE SENSITIVITY ON THE DEVICE WAS SET HIGHER IN THE ATRIUM. NO ADDITIONAL 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 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R