BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1984463 · Received February 1, 2011

    Report

    Report Number
    1028232-2011-00187
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 24, 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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACER DEPENDENT PATIENT WITH ATRIAL FIBRILLATION WAS SYNCOPAL. THRESHOLD AND IMPEDANCE MEASUREMENTS WERE NORMAL, BUT SENSING HAD DECREASED AND R-WAVES WERE NORMAL, BUT SENSING HAD DECREASED AND R-WAVES WERE VARYING IN SIZE. DAILY MEASUREMENTS LOOKED FINE. TECHNICAL SERVICES NOTED THAT SINCE THIS IS A NEW IMPLANT, THERE COULD BE LEAD MOVEMENT OR LOSS OF CAPTURE BASED ON THE PATIENT'S SYMPTOMS. THE PATIENT'S SON WAS PRESENT DURING HIS SYNCOPAL EPISODE AND NOTED THE PATIENT HAD A PULSE THE 15 MINUTES HE WAS PASSED OUT. ALL EVIDENCE INDICATES THE PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    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 Other