BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 1922977 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06021
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 THE PRESENCE OF OVERSENSING. TWO EPISODES OF SHORT V-V CYCLE SENSED EVENTS WERE RECORDED. ONE OCCURRING ON (B)(6) 2010 AND ONE ON (B)(6) 2010. THESE TYPE OF EPISODES CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM.

    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 THE DEVICE WAS OVERSENSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD