BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2810870 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06286
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 31, 2012
    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
    MA, US
    Reporter Occupation
    HEALTH 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. 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 WERE POWER ON RESET (POR) PARAMETERS WITH ONE POR FOR WRITE TO LOCKED RAM, ADDR=15C1, DATA=6 ON (B)(6) 2012. THERE WAS ONE PATIENT ALERT FOR POR ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A POWER ON RESET (POR) WHICH SOUNDED A PATIENT ALERT. THE POR WAS CLEARED, ALERTS WERE RELOADED, 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
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD