BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4137

    MDR report key: 2904341 · Received December 4, 2012

    Report

    Report Number
    1028232-2012-03107
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    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 MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING 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

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 6 WEEKS IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS NOT CAPTURING. THE PATIENT HAD UNDERGONE A REVISION PROCEDURE OF THIS LEAD DUE TO DISLODGMENT TWO WEEKS BEFORE (ON (B)(6) 2012). NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. DUE TO THE GENERAL HEALTH CONDITION OF THE PATIENT (REFRACTORY HEART FAILURE AND SEVERE KIDNEY FAILURE) IT WAS DECIDED NOT TO INTERVENE APART FORM REPROGRAMMING THE LEFT VENTRICULAR CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG. 360313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other