BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 2203222 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01418
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    January 2, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET. THE DEVICE WAS REPROGRAMMED AND IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF TH EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention