BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2790892 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05331
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 24, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. DEVICE EXPERIENCED A CRITICAL RAM PARITY ERROR POWER ON RESET (POR) ON (B)(4) 2012 IN LOCATION "0D D5". DEVICE SHOULD BE ABLE TO RECOVER FROM THE EVENT AND CONTINUE NORMAL FUNCTION. RADIATION TREATMENT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD TWO ELECTRICAL RESETS. THE FIRST TIME THE DEVICE RESET TO VVI65, AND THE SECOND TIME THERE WAS A WARNING THAT BATTERY AND LEAD MEASUREMENTS WERE NOT ABLE TO BE MEASURED. IT WAS NOTED THAT THE PATIENT WAS UNDERGOING RADIATION TREATMENT AT THE TIME. THE DEVICE REMAINS 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
    1 REVO MRI SURESCAN IMPLANTABLE PULSE GENERATOR LWP MEDTRONIC MED REL, INC. RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 5086MRI X2 IMPLANTABLE PACING LEADS