BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2130647 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03363
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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. 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. THE SAVE TO DISK FILE (B)(6) SHOWS 1 - PARITY ERROR LOG, ADDR=2283, DATA=6, ON (B)(6) 2011 15:09:46.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHECK, THERE WERE QUESTION MARKS IN THE QUICK LOOK EPISODES. HOWEVER, AT A SECONDARY FOLLOW UP ALL EPISODES DISPLAYED CORRECTLY. 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 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD