BEUDAMED
    FDA Adverse Event Summary report: N

    INTRINSIC

    MDR report key: 1863212 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05108
    Date Received
    October 9, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED POWER ON RESET (POR) PARAMETERS. WRITE TO LOCKED RANDOM ACCESS MEMORY POR RECORDED ON (B)(6) 2010. THE POR SEVERITY WAS LOW. 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.

    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 PATIENT EXPERIENCED 4 SHOCKS. UPON INTERROGATING THE DEVICE THE DOCTOR WAS UNABLE TO RETRIEVE STORED EVENTS DUE TO A POWER ON RESET (POR). PATIENT HAD BEEN RECEIVING RADIATION THERAPY. SYSTEM STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 Life Threatening 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD