BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1983027 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00888
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD BEEN IN AND OUT OF THE HOSP. THE STIMULATION HAD BEEN TURNED UP AND THE PT WAS ABLE TO EAT A SANDWICH AND WAS TOLERATING LIQUIDS. THE PT WAS LAST SEEN BY THIS HEALTHCARE PROVIDER (B)(6) 2010 AND WAS TOLERATING LIQUIDS. SEE ALSO MFR'S REPORT # 3004209178-2010-09497 REGARDING PREVIOUS STIMULATOR EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization LEAD: MODEL 4351, LOT# NHT002195N| EXPLANTED: NA| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT002194N| IMPLANTED:| EXPLANTED: