BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2294244 · Received October 13, 2011

    Report

    Report Number
    6000094-2011-02129
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4). PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED REVEALING HIGH RESISTANCE/IMPEDANCE. THERE WERE 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE: 10-JUN-2011 09:00:11 AND 16-AUG-2011 09:00:11. THE WEEKLY HV IMPEDANCE TREND DATA SHOWED HIGH IMPEDANCE FOR MAX SVC DEFIB IMPEDANCE= 118 TO 254 OHMS RANGE BETWEEN 06-JUN-2010 AND 15-AUG-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE APPEARED TO HAVE A LOSE SETSCREW ISSUE. THE DEVICE IS STILL 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
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D234TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other