BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3092637 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01527
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN HOSPITALIZED FOR ABOUT 1 MONTH FOR "BEING SEPTIC OF YEAST AND (B)(6) AND A COUPLE OTHER BACTERIA'S." IT WAS ADDED ABOUT 1 WEEK PRIOR TO THIS REPORT, PATIENT STARTED HURTING "REALLY BAD ALL OVER FROM THE NECK DOWN AND COULDN'T USE THEIR ARMS OR LEGS." THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND GETTING PAIN MEDICATION THAT HELPED RELAX THEIR ARMS AND LEGS SO THEY CAN MOVE AND USE THEM. IT WAS NOTED A MYELOGRAM WAS SCHEDULED FOR THE END OF THE WEEK. THE HEALTHCARE PROVIDER HAD RULED OUT THE PATIENT'S RHEUMATOID AS A CAUSE. IT WAS ADDED THE HEALTHCARE PROVIDER THOUGHT A PORTION OF THE PAIN THE PATIENT WAS FEELING MAY BE PSYCHOLOGICAL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194542 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R