BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 1033769 · Received April 25, 2008

    Report

    Report Number
    1028232-2008-00467
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 27, 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 INFO THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS DISLODGED AS A RESULT OF THE PT PERFORMING STRETCHING EXERCISES. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. IT IS UNK IF THIS LEAD WAS REVISED OR EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization