BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 3210164 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07200
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 DURING SCHEDULED DEVICE REPLACEMENT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD BECAME STUCK IN A A RETRACTOR THE PHYSICIAN WAS USING TO STOP BLEEDING. A CONDUCTOR BREAK COULD BE VISUALIZED THROUGH THE INSULATION. THE LEAD EXHIBITED NO CAPTURE, NO SENSING AND OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEAD WAS SURGICALLY ABANDONED AND A NEW RA LEAD IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310591 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4244

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 1290| K173| 4244| 1274| 4470| 4035