BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 1989302 · Received February 14, 2011

    Report

    Report Number
    6000144-2011-00578
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    November 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ONE - POR (POWER ON RESET) FOR WRITE TO LOCKED RAM, ADDRESS=168F, DATA=04 ON (B)(6) 2010 17:15:36. ONE - PATIENT ALERT FOR POR ON (B)(6) 2010 17:15:36.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE HAD A RESET. PATIENT IS HAVING RADIATION THERAPY. DEVICE IS STILL 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 DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other 6945 IMPLANTABLE TACHY LEAD| 4261 COMPETITOR IMPLANTABLE PACING LEAD| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 4261 COMPETITOR IMPLANTABLE PACING LEAD