BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 1072832 · Received July 10, 2008

    Report

    Report Number
    6000144-2008-00156
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 27, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: ANALYSIS CONFIRMED THE REPORTED POR (POWER ON RESET) CONDITION. HARDWARE MONITORS THE MICROPROCESSOR FOR ANY ATTEMPT TO PERFORM AN UNRECOGNIZED OR ILLEGAL OPERATION. WHEN THIS OCCURS, IT WILL GENERATE A SPECIAL INTERRUPT TO CAUSE THE FIRMWARE TO RESET ITSELF AND THE DEVICE. THE DEVICE SHOULD BE ABLE TO RECOVER FROM THIS TYPE OF RESET. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD