BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 2052607 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03498
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 24, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS REPORT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE, LOW IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 320 MO Required Intervention (B)(4)| 1298| 4269| (B)(4)