BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2062999 · Received April 11, 2011

    Report

    Report Number
    1028232-2011-00822
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BIOTRONIK SE AND 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 RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING LOW R-WAVES AND WAS NOT CAPTURING AT 6.5V/1.0MS. THE LEAD WAS REPOSITIONED, THEN EXHIBITED THE SAME ISSUE AGAIN. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization