BEUDAMED
    FDA Adverse Event Summary report: N

    ENRHYTHM DR

    MDR report key: 1863216 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05111
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 RESULTS REVEALED THE PRESENCE OF POWER ON RESET (POR) PARAMETERS. THIS POR SEVERITY IS 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 LINEAR ACCELERATOR X-RAY RADIATION FOR CANCER THERAPY. PARITY ERRORS WERE RECORDED ON (B)(4) 2010, (B)(4) 2010, (B)(4) 2010, & (B)(4) 2010.

    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

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED. THE PATIENT HAS BEEN RECEIVING RADIATION TREATMENT. 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 ENRHYTHM DR ASKU DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4076 (X2) IMPLANTABLE PACING LEAD| 4076 (X2) IMPLANTABLE PACING LEAD