BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II DR

    MDR report key: 4161358 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02295
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE RETURNED DEVICE INDICATED A SET SCREW WITH A ROUNDED SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE TRYING TO IMPLANT THE ATRIAL LEAD, THERE APPEARED A NOISE. "THE PHYSICIAN THREW THE LEAD AND IT LEFT." IT WAS ALSO NOTED THAT IT WAS IMPOSSIBLE TO UNSCREW THE LEAD AFTER SEVERAL ATTEMPTS DUE TO A SETSCREW PROBLEM. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642261 MAXIMO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D264DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 5076-52 LEAD