BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 2220007 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06184
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WOULD NOT INTERROGATE OUT OF THE BOX. THE DEVICE WOULD NOT PICK ON THE PROGRAMMER. SEVERAL ATTEMPTS WERE MADE WITH TWO DIFFERENT PROGRAMMERS. THE DEVICE ALSO WOULD NOT PICK ON THE RECHARGER. THE DEVICE WAS NOT INTRODUCED TO A PT.

    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 NA Unknown