BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 1243195 · Received November 10, 2008

    Report

    Report Number
    1028232-2008-01420
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 27, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXHIBITED LOSS OF CAPTURE AND LOW IMPEDANCE. PATIENT IS SCHEDULED FOR A LEAD REVISION SURGERY. NO ADVERSE PATIENT EFFECTS. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization