BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS

    MDR report key: 1863709 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15887
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RA LEAD WILL NOT BE RETURNED TO THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL (RA) LEAD HAS BEEN EXPLANTED AS A RESULT OF DISLODGEMENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS IMPLANTABLE LEAD NVN EXTERNAL MANUFACTURER 4135

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4076| 0185| 0158| S603| 4137| 4543| 4135| N119