BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2911514 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16161
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2011
    Report Date
    December 4, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ADDITIONAL INFORMATION INDICATES THAT NO SURGICAL INTERVENTION IS PLAN FOR THE TIME BEING. THE PATIENT ONLY USES THE LEAD ONE PERCENT OF THE TIME AND IS IN A SKILLED NURSING FACILITY AND IS BED RIDDEN. THERE HAS BEEN NO ASSOCIATED SYMPTOMS AND THE LEAD HAS GOOD SENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCES GREATER THAN 2,000 OHMS AND INCREASED PACING THRESHOLDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18753 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 4456| 4469| S603