BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 1863788 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16575
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE THE COMPANY WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXPERIENCED EXCESSIVE NOISE THAT CAUSED INAPPROPRIATE MODE SWITCHES. IT WAS SUSPECTED THAT THERE WAS SOME INSULATION OF CONDUCTOR DAMAGE, HOWEVER, THIS COULD NOT BE CONFIRMED. AS A RESULT, THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR T165| E110| 4470| 1810| 0125| 4269