BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1953681 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23831
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 22, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IMPLANTED. 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

    THE PATIENT LATER REPORTED THAT THEY WERE TOLD THAT ONE OF THEIR LEADS WAS LOOSE. IN ADDITION A CLINICAL STAFF HAD INDICATED THAT THE OUT OF RANGE MEASUREMENTS MAY BE RELATED TO A LEAD FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DETECTED AN INCREASE IN RIGHT VENTRICULAR PACING IMPEDANCES FROM 400 TO 2500 OHMS. IN ADDITION THERE IS NO CAPTURE OR SENSING. THE PATIENT WAS ONLY 4% PACED SINCE LAST RESET. IT WAS REPORTED THAT THE PHYSICIAN WAS CONSIDERING PROGRAMMING CHANGES WITH THIS PATIENT AS THIS PATIENT WAS VERY SICK, CAUSE NOT DEFINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR (B)(4)| (B)(4)| (B)(4)