BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3213776 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08639
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD WAS SEEN IN THE CLINIC FOR A ROUTINE DEVICE INTERROGATION, DURING WHICH, THE FIELD REPRESENTATIVE (REP) REPORTED DISCOVERING NOISE WHICH LED TO STORED EPISODES. THE REP WAS UNABLE TO RECREATE ANY NOISE. IT WAS ALSO REPORTED THAT A LEAD SAFETY SWITCH (LSS) HAD BEEN TRIGGERED, INDICATING AN OUT OF RANGE IMPEDANCE MEASUREMENT. DIAGNOSTICS WERE STABLE ON BOTH UNIPOLAR AND BIPOLAR SETTINGS. NO INTERVENTION HAS BEEN PERFORMED AND THE PATIENT WAS TO BE REEVALUATED AT A LATER DATE. AT THIS TIME, THE SOURCE OF THE CLINICAL OBSERVATIONS HAS NOT BEEN DETERMINED. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312482 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 1294| 4088| 4472