BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 1812828 · Received August 11, 2010

    Report

    Report Number
    1028232-2010-01724
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 12, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    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 RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A HELIX RETRACTION ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. OTHER THAN THE PROCEDURE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization