BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 2170284 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09828
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE OF ANOTHER MANUFACTURER'S DEVICE, THE TERMINAL PIN OF THIS IMPLANTABLE RIGHT ATRIAL (RA) LEAD BECAME SEPARATED FROM THE INSULATION. A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT RECOMMENDED THE LEAD BE REPLACED. THE LEAD WAS SURGICALLY ABANDONED AND A NEW RA LEAD SUCCESFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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 86 YR Hospitalization| R H135| 4513| 0125| 1810| 4269| 4403