BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2173702 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10775
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD WAS SUSPECTED OF A CONDUCTOR FRACTURE. IT WAS ALLEGED THAT INFARED SONOGRAPHY WAS THE SUSPECTED CAUSE. THERE WERE EPISODES OF NOISE WHICH LEAD TO THE STORAGE OF INAPPROPORIATE ATRIAL TACHYCARDIA RESPONSE (ATR) EVENTS. THERE HAS BEEN A GRADUAL INCREASE IN PACING IMPEDANCE MEASUREMENTS WITHIN THE LAST SIX MONTHS, HOWEVER THEY REMAINED WITHIN NORMAL LIMITS. THE SENSITIVITY WAS ADJUSTED, HOWEVER THERE ARE NO PLANS FOR INVASIVE INTERVENTION AT THIS TIME. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 4470| S602| 1286| 4457