BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3041261 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-04802
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    July 1, 2012
    Report Date
    January 9, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD SAFETY SWITCH (LSS) FOR OUT-OF-RANGE (OOR) ONCE SEVERAL MONTHS AGO, AND AGAIN JUST RECENTLY. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) WAS QUESTIONING WHY THEY COULDN'T SEE THE OOR IN THE LOGBOOK. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT THE OOR READING WAS AVERAGED INTO THE WEEKLY AVERAGES. THERE WERE A WIDE RANGE OF MEASUREMENTS IN THE AVERAGES, SOME IN THE 770 OHMS RANGE, AND SOME IN THE 300-400 OHMS RANGE. THERE WAS ALSO NOTED TO BE NOISE IN BOTH UNIPOLAR AND BIPLOAR CONFIGURATIONS, WHICH WERE ABLE TO BE RECREATED WITH ISOMETRICS. TS SUGGESTED ALL INDICATIONS POINT TO A LEAD ISSUE. THE PATIENT HAS SINCE MOVED OUT OF STATE AND HASN'T BEEN SEEN SINCE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142787 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4473| S403| 4474