BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1111646 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04912
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF HIS NAUSEA AND VOMITING SYMPTOMS AFTER EXPOSURE TO A SECURITY GATE. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention STIM ACCESSORY: MODEL 4351| STIM ACCESSOR: MODEL 4351| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: