BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2062424 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-02762
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS IN A POWER ON RESET CONDITION (POR). IT WAS STATED THAT THE PT WOKE UP ON (B)(6) 2011, AT 2:00AM, AND HAD A RETURN OF SYMPTOMS. SHE CHECKED HER PT PROGRAMMER, WHICH SHOWED THE DEVICE WAS IN A POR STATE. THE REPORTER STATED THERE IS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT, AND THE PT HAD NOT HAD ANY MEDICAL PROCEDURES. THE PT WAS ABLE TO GET STIMULATION RESTORED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 57 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V530126| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ108231N| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU052604V| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU052602V| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V553429