BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4136

    MDR report key: 1900269 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02515
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    November 2, 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 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 MANUFACTURING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM REC'D INFO THAT THIS PT PRESENTED TO THE HOSP WITH SYNCOPAL EPISODES. AT THE LAST DEVICE CHECK THE LEADS IMPEDANCE MEASUREMENTS WERE 800 OHMS AND RISING. NOW IMPEDANCE MEASUREMENTS ARE 1500 OHMS BIPOLAR AND 1301 UNIPOLAR. THE LEAD WILL BE LEFT IMPLANTED AND OBSERVED FOR NOW. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PT EFFECTS REPORTED. NO FURTHER INTERVENTION WAS UNDERTAKEN. THE EVENT WILL BE REOPENED IF ADDITIONAL INFO IS REC'D.

    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