BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2704595 · Received August 17, 2012

    Report

    Report Number
    3004209178-2012-07029
    Event Type
    Injury
    Date Received
    August 17, 2012
    Report Date
    July 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A ''HORRIBLE GATE'' AND HAD FALLEN DOWN SEVERAL TIMES. IT WAS NOTED THAT NO DETAILS ABOUT THE FALLS WERE GIVEN BY THE PATIENT. THE PATIENT STATED THAT ''SHE WAS DRIVING TO THE LEFT SINCE THE SURGERY.'' IT WAS NOTED THAT THE PATIENT HAD BEEN ADJUSTED TWICE. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT HAD NO CONCERNS REGARDING THEIR THERAPY/DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other