BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRINSIC

    MDR report key: 1854725 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04440
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A POWER ON RESET (POR) OCCURRED. (B)(4). IT WAS NOTED THAT THE POR SEVERITY IS LOW AND THAT THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. PARITY ERRORS ARE KNOWN TO OCCUR WITH HIGH PROBABILITY IN PATIENTS WHO RECEIVE RADIATION THERAPY. CORRECTED DATA: PATIENT DATE OF DEATH AND REMOVED DEVICE REMAINS ACTIVATED DEVICE CODE.

    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 HAD AN ELECTRICAL RESET. THE PATIENT IS RECEIVING RADIATION THERAPY. 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 INTRINSIC ASKU LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 4470 NON-MEDTRONIC IMPLANTABLE PACING LEAD| 0148 NON-MEDTRONIC IMPLANTABLE TACHY LEAD| 0148 NON-MEDTRONIC IMPLANTABLE TACHY LEAD| 4470 NON-MEDTRONIC IMPLANTABLE PACING LEAD