BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1140270 · Received August 29, 2008

    Report

    Report Number
    1028232-2008-01043
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    April 17, 2008
    Report Date
    July 25, 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 REC'D INFO THAT DURING A STRESS TEST, THIS PT EXHIBITED SOME EPISODES OF VENTRICULAR TACHYCARDIA WITH ISCHEMIA. THE PT'S THRESHOLDS HAD INCREASED AND LOSS OF VENTRICULAR CAPTURE WAS NOTED. AUTO CAPTURE WAS ON AND THE DEVICE WAS PACING IN RETRY MODE AT 3.5V. A PROCEDURE WAS PERFORMED TO REPOSITION THE RV LEAD AND DURING THIS PROCEDURE, THE PHYSICIAN NOTED THE LEAD WAS DISLODGED. HE REPOSITIONED THE LEAD AND IT DISLODGED AGAIN THE NEXT DAY. THE PHYSICIAN ELECTED TO EXPLANT THE DISLODGED LEAD AND REPLACE IT WITH A DIFFERENT MODEL DUE TO TISSUE IN THE HELIX. NO ADVERSE PT EFFECTS WERE REPORTED.

    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