BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 1921349 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05739
    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
    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. ANALYSIS INDICATES THAT THERE WERE TWO PATIENT ALERTS FOR ATRIAL PACE LEAD IMPEDANCE "NOT TAKEN" OCCURRING ON (B)(6) 2010 AND (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THE ICD ALERT TONE. THE PATIENT HAS A HISTORY OF FAR-FIELD OVERSENSING ON THE ATRIAL LEAD. BOTH THE ICD AND ATRIAL ARE 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 73 YR Other 6947 IMPLANTABLE TACHY LEAD