BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4135

    MDR report key: 2240589 · Received August 19, 2011

    Report

    Report Number
    1028232-2011-01855
    Event Type
    Other
    Date Received
    August 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 8, 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 MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. ELEVATED THRESHOLDS WERE NOTED AT A F/U, AND A CHEST X-RAY WAS TAKEN TO CONFIRM THE DISLODGEMENT. NO SURGICAL INTERVENTION HAS YET BEEN TAKEN. NO ADVERSE PT EFFECTS WERE REPORTED. THE LEAD WAS REPROGRAMMED AND REMAINS IN SERVICE. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

    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 Other