BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 2042429 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01189
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING ELEVATED THRESHOLD MEASUREMENTS AND OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS REVEALED AND THE LEAD WAS REMOVED FROM SERVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN 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 76 YR 5068| 1230| 4269