BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1991945 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00964
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 20, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, IT WAS NOT POSSIBLE TO CONNECT THE LEAD IN THE DEVICE BECAUSE THE SETSCREW WAS BLOCKED. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other