BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVO MRI SURESCAN

    MDR report key: 4162342 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19403
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL ELECTRICAL RESET. CRITICAL RAM PARITY ERROR OCCURRED IN (B)(4) ON (B)(6) 2014. POWER ON RESET (POR) SEVERITY IS LOW SO THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. CONCOMITANT PRODUCT: 5086MRI52 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET WAS OBSERVED ON A REMOTE MONITORING TRANSMISSION. THE PATIENT WAS NOTED TO HAVE BEEN SCHEDULED FOR RADIATION TREATMENT; HOWEVER, THERE WAS NO CONFIRMATION THAT THIS HAD OCCURRED. 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
    639200 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR 5086MRI58 LEAD