BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 2833048 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02742
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED INCLUDING A VISUAL, A MECHANICAL AND A ELECTRICAL INSPECTION. THE ANALYSIS OF THE LEAD DEMONSTRATED MULTIPLE SIGNS OF ABRASION. BASED ON THE CHARACTERISTIC OF THIS DAMAGE IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. AN INTERACTION BETWEEN THE LEAD AND A PARTNER LEAD SHOULD BE TAKEN INTO CONSIDERATION. THE CUTTINGS IN THE INSULATION AND THE PARTLY SEPARATED LEAD TIP OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. THEREFORE IN THE COURSE OF THE ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED. DIAPHRAGMATIC STIMULATION WAS OBSERVED. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization