BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1981390 · Received February 1, 2011

    Report

    Report Number
    3004209178-2011-00775
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS STRUCK BY A SOCCER BALL. AFTERWARD HE FELT PAIN IN HIS LEFT SIDE ARM AND LEG. HIS TOES CURLED UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR LEAD: MODEL 3389S-40, LOT# V397842| EXPLANTED: UNK| LEAD: MODEL 3389S-40, LOT# V397842| EXPLANTED: UNK| EXTENSION: MODEL 37085, LOT# NKN005492V| EXPLANTED: UNK| IMPLANTED:| IMPLANTED:| EXPLANTED: UNK| EXTENSION: MODEL 37085, LOT# NKN005502V| PROGRAMMER: MODEL 37642, LOT# NJZ104007N| IMPLANTED:| IMPLANTED: