BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2695954 · Received August 14, 2012

    Report

    Report Number
    6000144-2012-04376
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    December 31, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    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. THERE WAS ONE POWER ON RESET (POR) FOR WRITE TO LOCKED RAM, ADDR=10A4, DATA=0 ON (B)(6) 2011 15:22:56. A PATIENT ALERT FOR POR OCCURRED ON (B)(6) 2011 15:22:56. DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET WAS NOTED UPON INTERROGATION. A PATIENT ALERT HAD TRIGGERED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE NOTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD