BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 4170500 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02969
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    November 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDWATCH FILED IN ERROR AS EVENT WAS PREVIOUSLY REPORTED. INITIAL MEDWATCH OF THIS SUPPLEMENTAL, CORRECTIVE MDR IS BEING REDACTED AS IT IS A DUPLICATE MEDWATCH. SEE MANUFACTURER REPORT # 3004209178-2011-09630.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS REMOVED DUE TO STAPHYLOCOCCUS INFECTION. THE PATIENT WAS SENT TO INFECTIOUS DISEASE CONTROL. PRIOR MEDICAL STATUS, TREATMENT/INTERVENTIONS, CLINICAL COURSE, CAUSE, AND PATIENT OUTCOME WERE NOT GIVEN. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651445 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R