BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3991686 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14245
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: 5086MRI-58 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED. THERE WERE FIVE INSTANCES OF SINGLE BIT ECC-ERROR ON THE FOLLOWING DATES, TIMES AND LOCATIONS: (B)(4) 2014 3:46:01 PM AT LOCATION CC, (B)(4) 2014 AT 7:35:19 PM AT LOCATION 09, (B)(4) 2014 AT 4:04:08 PM AT LOCATION 00, (B)(4) 2014 AT 4:04:21 PM AT LOCATION 16, AND (B)(4) 2014 AT 4:04:22 PM AT LOCATION 00.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INVALID DATA WAS PRESENTED IN THE DEVICE DIAGNOSTICS. THE PATIENT WAS NOTED TO BE UNDERGOING RADIATION TREATMENT. 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
    467802 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 5086MRI-52 LEAD