BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1053246 · Received May 28, 2008

    Report

    Report Number
    3004209178-2008-02837
    Event Type
    Injury
    Date Received
    May 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN ENTERRA DEVICE WAS BLEEDING FROM THE MOUTH AND WAS TAKEN TO THE HOSPITAL. THE PATIENT'S DEVICE MAY HAVE BEEN TURNED OFF/INTERFERED WITH FROM WALKING THROUGH SECURITY DOORS AT A PRISON FACILITY. FURTHER INFORMATION 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. 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT # NHT006051N| LEAD: MODEL 4351, LOT # NHT005226N| EXPLANTED:| IMPLANTED: