BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA PC

    MDR report key: 2073589 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03114
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    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 Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL TWO DAYS BEFORE THE REPORT, AND HAD TO GET A SURGICAL PROCEDURE TO "RELIEVE PRESSURE". SINCE THE PROCEDURE, THE PT WAS DOING BETTER. THE PT WAS SEEN (B)(6) 2011 AND THE SETTINGS WERE CHECKED AND EVERYTHING WAS FINE. THE DATE OF THE REPORT THE PT HAD A LITTLE DYSKINESIA IN THE MORNING. REVIEW WITH THE PT PROGRAMMED INDICATED THAT THE PT'S STIMULATOR WAS ON AND AT THE CORRECT SETTINGS. INFORMATION REGARDING USING THE PT PROGRAMMER WAS GOING TO BE SENT FOR FURTHER REFERENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 64 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V556377| EXTENSION: MODEL 37085, LOT# NKN014878V| IMPLANTED: