BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2895992 · Received November 19, 2012

    Report

    Report Number
    1028232-2012-02974
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    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.

    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 RECEIVED INFO THAT THIS LEAD EXHIBITED A LEAD SAFETY SWITCH (LSS) WHICH OCCURRED INITIALLY SEVERAL MONTHS AGO. THE IMPEDANCE WENT FROM 2200 OHMS DOWN TO 450 OHMS. IN THE RECENT OFFICE VISIT, THE IMPEDANCE WAS SHOWING AT GREATER THAN 2500 OHMS. THE PT IS NOT DEPENDANT ON RIGHT VENTRICULAR THERAPY, HOWEVER REPORTED FEELING TIRED. SOME PROGRAMMING CHANGES WERE DONE TO ALLEVIATE THE ISSUE. TO DATE, NO ADVERSE PT EFFECTS HAVE BEEN REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADD'L INFO BE PROVIDED.

    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