BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2190361 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05720
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A SUCCESSFUL IMPLANTATION, BUT AFTER "SOME TIME" SKIN EROSION APPEARED IN THE SUBCLAVICULAR AREA WHERE THE NEUROSTIMULATOR WAS IMPLANTED. THE PHYSICIAN BELIEVED THE SKIT EROSION MAY HAVE BEEN DUE TO THE SHARP EDGES OF THE NEUROSTIMULATOR. THE PT UNDERWENT A REVISION ON (B)(6) 2011 TO REPOSITION THE DEVICE. THE PT WAS "DOING BETTER" BUT THE PHYSICIAN WAS WORRIED SKIN EROSION MAY REOCCUR. IT WAS REPORTED THAT NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention