BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2203303 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04321
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 4, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A POWER ON RESET (POR) OF THE PARAMETERS. THERE WAS ONE POR FOR WRITE TO LOCKED RAM, ADDR=19A5, DATA=B4, ON (B)(4)-2011 16:31:13 AND ONE PATIENT ALERT FOR POR ON (B)(4)-2011 15:31:13.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET. THE DEVICE WAS REPROGRAMMED AND 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 63 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD