BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1863167 · Received October 9, 2010

    Report

    Report Number
    6000094-2010-01927
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT THE DEVICE DID NOT RECOGNIZE THE PRESENCE OF THE SVC COIL. THE DEVICE WAS NOT USED. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D234TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other