BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 2053186 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01597
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    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
    ND, 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. WEEKLY LEAD IMPEDANCE DATA SHOWS VARIOUS UN-FILTERED POINTS WITH "N/T" (NOT TAKEN) FOR MIN AND MAX A PACE, BETWEEN (B)(4)-2009 AND (B)(4)-2011. 1- PATIENT ALERT FOR A.PACE LEAD Z="NOT TAKEN" ON (B)(4)-2007 03:00:07.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLIPPED BIT OCCURRED IN THE DIAGNOSTICS AREA OF THE DEVICE WHICH CAUSED THE LEAD TREND DATA TO BE UNVIEWABLE. 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 DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 6948 IMPLANTABLE TACHY LEAD| 4574 IMPLANTABLE PACING LEAD