BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES SR

    MDR report key: 2134052 · Received June 20, 2011

    Report

    Report Number
    6000094-2011-01053
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    April 12, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S14
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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.

    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. POWER ON RESET - POWER ON RESET PARAMETERS. POR WITH REASON CODES "DCLK EDGES, CLKSTOP STATUS". COINCIDED WITH RADIATION THERAPY. DEVICE RECOVERED AFTER RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET AFTER PATIENT HAD PROTON RADIATION THERAPY. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED BACK TO PREVIOUS SETTINGS AND REMAINS 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 DA+ C SERIES SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. C20A1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention