BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4136

    MDR report key: 1883305 · Received October 22, 2010

    Report

    Report Number
    1028232-2010-02130
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 22, 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 MFG. TYPE OF REPORTABLE EVENT: SUSPECTED DISLODGEMENT WITHOUT INTERVENTION.

    Description of Event or Problem · 1

    AFTER AN IMPLANT DURATION OF APPROX 4 DAYS LOSS OF CAPTURE (SUSPECTED DUE TO DISLODGEMENT) WAS REPORTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THERE WAS NO EXPLANT DATE PROVIDED OR ANY INDICATION THAT THE LEAD WAS EXPLANTED OR REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other