BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2951692 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01586
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE 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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. 1 - POR FOR WRITE TO LOCKED RAM, ADDR=18B1, DATA=95 ON (B)(6) 2012 03:03:09. 1 - PATIENT ALERT FOR POR ON (B)(6) 2012 02:03:09. CONCOMITANT PRODUCTS: YRBRX2615165 IMPLANTABLE STENT GRAFT - (B)(6) 2004. YRECX20375 IMPLANTABLE STENT GRAFT - (B)(6) 2004. YRIRX16115 IMPLANTABLE STENT GRAFT - (B)(6) 2004. YRIRX1685 IMPLANTABLE STENT GRAFT - (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET. THE RESET WAS CLEARED, AND 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
    56356 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD