BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2895986 · Received November 19, 2012

    Report

    Report Number
    1028232-2012-02973
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    August 17, 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 EVAL. 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 THE RV LEAD EXHIBITED NOISE LEADING TO INAPPROPRIATE VT EPISODES. THE NOISE WAS ALSO OVERSENSED AND INHIBITED PACING FOR APPROX TWO SECONDS, THE PT IS NOT PACEMAKER DEPENDENT. DURING THE DEVICE INTERROGATION, THEY WERE UNABLE TO REPRODUCE THE NOISE WITH POCKET MANIPULATION AND PT ISOMETRICS. WHEN THE LEAD WAS REPROGRAMMED TO UNIPOLAR SENSING, LESS NOISE WAS OBSERVED. THE RV LEAD THRESHOLD WAS AT 1 VOLT AND THE R-WAVES VARIED FROM 4 TO 4.75 MV. HOWEVER, THE IMPEDANCE MEASUREMENT WAS LOW AT 211 OHMS. REVIEW OF THE DAILY MEASUREMENTS REVEALED VARYING IMPEDANCE MEASUREMENTS FROM 148 TO 548 OHMS. TECH SERVICES NOTED THAT ALL OF THE EPISODES WERE TRIGGERED BY NOISE ON THE VENTRICULAR CHANNEL. OF THE EPISODES SENT IN, THE NOISE DOES NOT APPEAR TO INHIBIT PACING. TECH SERVICES ADVISED THAT THE NOISE INDICATES POTENTIAL RV LEAD ISSUE. NO ADD'L INFO IS CURRENTLY AVAILABLE. IF ADD'L INFO BECOMES AVAILABLE, THE EVENT WILL BE UPDATED. SINCE THE DEVICE IS APPROACHING ERI, THE PHYSICIAN HAS OPTED TO WAIT UNTIL THE NORMAL CHANGE OUT PROCEDURE TO REVISE THE LEAD. NO ADVERSE PT EFFECTS WERE REPORTED.

    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