BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2182199 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05168
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 13, 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
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PAIN AT THE BACK RIGHT SIDE OF THE SKULL, FOLLOWING THE USE OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) FOR PHYSICAL THERAPY PERFORMED ON THE PT'S RIGHT KNEE. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADDITIONAL INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 EXTENSION: MODEL 37085, LOT# NKN003764V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V333236| IMPLANTED:| LEAD: MODEL 3387S, LOT# V333236| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ102588N| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN003860V