BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3041157 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01249
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    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 DEVICE SYSTEM DETECTED A LEAD SAFETY SWITCH ON THE RIGHT VENTRICULAR (RV) LEAD GREATER THAN 2,500 OHMS IN THE UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE SALES REPRESENTATIVE WAS TO FURTHER DISCUSS WITH THE PATIENTS PHYSICIAN. INFORMATION WAS RECEIVED THAT TO DATE, NO X-RAY WAS PERFORMED, HOWEVER, THE PATIENT WAS TO BE SCHEDULED FOR A LEAD REVISION PROCEDURE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WITH THIS LEAD THAT FOLLOWING A FALL ONTO A PADDED KNOB, THE PATIENT BEGAN TO FEEL DIFFERENT ONCE THE LEAD HAD FRACTURED. THE PATIENT ALSO NOTED THAT ONCE THE LEAD WAS FRACTURED, THE PHYSICIAN ALSO DISCOVERED THE PATIENT WAS ENDURING ATRIAL FIBRILLATION (AF).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS OBSERVED TO BE FRACTURED, RESULTING IN THE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITHOUT COMPLICATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143132 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 4457| 1290| 4480