BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 2170712 · Received July 12, 2011

    Report

    Report Number
    1028232-2011-01526
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 23, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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 RECEIVED INFO THAT DURING A ROUTINE DEVICE CHECK, THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED AND ON FLUOROSCOPY, THE LEAD WAS NOTED TO BE IN THE RIGHT VENTRICLE. THE LEAD WAS EXPLANTED AND A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED AND THE LEAD WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization