BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 4250993 · Received November 14, 2014

    Report

    Report Number
    1028232-2014-004094
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 29, 2014
    Report Date
    November 6, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE VISUAL INSPECTION, CUTTINGS IN THE INSULATION WERE FOUND. IT IS REASONABLE TO ASSUME, THAT THE CUTTINGS RESULTED FROM THE EXPLANTATION PROCEDURE. BLOOD PENETRATED THE LEAD IN THE CUT AREAS. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE MECHANICAL ANALYSIS OF THE FIXATION MECHANISM WERE WITHIN THE TECHNICAL SPECIFICATIONS. IN SUMMARY, THE LEAD PRESENTED CUTTINGS IN THE INSULATION, WHICH RESULTED PRESUMABLY FROM THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 1 MONTH, DURING A FOLLOW-UP, IT WAS NOTED ON AN X-RAY THAT THIS RIGHT VENTRICULAR LEAD DISLODGED INTO THE ATRIUM. THE LEAD WAS REPLACED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737095 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 360312

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization