BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1201562 · Received October 16, 2008

    Report

    Report Number
    1028232-2008-01264
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED ON SEVERAL OCCASIONS SINCE INITIAL IMPLANT ABOUT ONE MONTH AGO. THIS EVENT IS THE SECOND REVISION THAT HAS OCCURRED ON THIS LEAD DUE TO DISLODGEMENT, SO THE PHYSICIAN OPTED TO USE A NEW LEAD. A NEW LEAD WAS IMPLANTED AND TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization