BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2121476 · Received June 7, 2011

    Report

    Report Number
    1028232-2011-01244
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 30, 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 REC'D INFO THAT DURING THE IMPLANT OF THIS LEAD FOR A DEVICE UPGRADE, THE PT EXPERIENCED TAMPONADE. DURING THE SUBSEQUENT EVENTS, THE LEAD BECAME UNSTERILE AND WAS NOT USED. ADD'L INFO WAS OBTAINED AND THE PHYSICIAN SUSPECTED THE TAMPONADE WAS CAUSED BY A DISSECTION OR PERFORATION THAT TOOK PLACE AT SOME POINT DURING THE IMPLANT. THE LEAD WAS REMOVED. NO FURTHER INFO IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization