BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2955448 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02077
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 2, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY - PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THERE WERE POWER ON RESET PARAMETERS. A CRITICAL RANDOM ACCESS MEMORYPARITY ERROR WAS LOGGED ON (B)(6) 2012. THE POWER ON RESET SEVERITY IS CONSIDERED LOW AS DEVICE SHOULD BE ABLE TO RECOVER FULLY AFTER RESET. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET. THE RESET WAS CLEARED. 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
    59000 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention 5086 X 2 IMPLANTABLE PACING LEADS