BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 1921285 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05722
    Event Type
    Malfunction
    Date Received
    December 13, 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
    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. ANALYSIS RESULTS REVEALED THE PRESENCE OF POWER ON RESET (POR) PARAMETERS THERE WAS 1 PATIENT ALERT LOG ENTRY FOR POR ON (B)(6) 2010. THERE WERE 3 POR LOG ENTRIES FOR WRITE TO LOCKED RAM (NOTES SHOW RADIATION THERAPY USED) BETWEEN (B)(6) 2010 AND (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE HAD AN ELECTRICAL RESET, POSSIBLY DUE TO RADIATION THERAPY. IT WAS ALSO NOTED THAT UPON PLACING THE PROGRAMMER HEAD OVER THE DEVICE, THE ALARM TONE WAS SOLID FOR SEVERAL SECONDS AND THEN SWITCHED TO A BEEPING TONE. THE 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 72 YR Other 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD