BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 2160922 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04533
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A RETURN OF SYMPTOMS AFTER PASSING THROUGH A SECURITY GATE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 37642, LOT# NJZ105252N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37651, LOT# NKA126014N| EXTENSION: MODEL 37085, LOT# NKN004968V| EXTENSION: MODEL 37085, LOT# NKN009922V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0309590V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0313854V| EXPLANTED: