BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1841089 · Received September 16, 2010

    Report

    Report Number
    1028232-2010-01885
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 16, 2010
    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 ASSOCIATED WITH THE MFR OF 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 CRM RECEIVED INFO THAT THE RIGHT VENTRICULAR (RV) LEAD R-WAVE AMPLITUDE WAS MEASURING LOW AT 0.9MV. A LEAD REVISION WAS SUCCESSFULLY PERFORMED, AFTER WHICH THE RV LEAD MEASUREMENTS WERE: 1500 OHM LEAD IMPEDANCE, 15 MV R-WAVE AMPLITUDE AND 1V THRESHOLD. NO ADVERSE PT EFFECTS WERE REPORTED. AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADD'L INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    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 Hospitalization