BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 2051615 · Received April 12, 2011

    Report

    Report Number
    6000094-2011-00491
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 19, 2001
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE SET SCREW WAS LOOSE/DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WS DIFFICULT TO INSERT THE SETSCREW WRENCH INTO THE PORT, ONCE INSERTED THE SCREW WOULD NOT TIGHTEN. THE DEVICE WAS ATTEMPTED, BUT NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D234DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other