BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 1926386 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09274
    Event Type
    Injury
    Date Received
    November 11, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NOTED THE OUT OF REGULATION WARNING MESSAGE (OOR) OCCURRED REPEATEDLY OVER ABOUT TWO WEEKS PRIOR TO THE REPORT. THE MESSAGE DISAPPEARED WHEN THE STIMULATOR WAS BEING CHARGED, AND RE-APPEARED AT BATTERY LEVEL OF 75%. THERAPY HAD NOT YET BEEN OPTIMIZED. A PARTIAL LOSS OF EFFECT WAS REPORTED TOGETHER WITH OOR, BUT WAS DIFFICULT TO ASSESS MORE PRECISELY. THE OOR OCCURRED TWICE DURING PHYSICIAN VISITS THE WEEK PRIOR TO THE REPORT. ON (B)(6) 2010, OOR WAS ACTIVE AND THE CLINICIAN PROGRAMMER SHOWED THE CORRESPONDING WARNING MESSAGE. IMPEDANCES WERE NORMAL ON ALL ELECTRODES. THERAPY IMPEDANCE WAS ALSO NORMAL. STIMULATION SETTINGS WERE TOO LOW TO EXPLAIN THE OCCURRENCE OF OOR. THE PHYSICIAN WAS PLANNING REPLACEMENT OF THE DEVICE. NO PT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female UNK.