BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1860988 · Received October 7, 2010

    Report

    Report Number
    6000094-2010-01948
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 20, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE OF DEVICE WAS LOW. ANOTHER DEVICE WAS USED. THE DEVICE WAS RETURNED IN THE SEALED PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other