BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA THERAPY

    MDR report key: 1102543 · Received August 8, 2008

    Report

    Report Number
    2950887-2008-04718
    Event Type
    Injury
    Date Received
    August 8, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE REFERENCE: LIN Z, ET AL. SYMPTOM RESPONSES, LONG-TERM OUTCOMES AND ADVERSE EVENTS BEYOND 3 YEARS OF HIGH-FREQUENCY GASTRIC ELECTRICAL STIMULATION FOR GASTROPARESIS. NEUROGASTROENTEROL MOTIL 2006;18:18-27. THE ARTICLE DISCUSSES SYMPTOM RESPONSES AND LONG-TERM OUTCOMES IN 55 GASTROPARETIC PATIENTS RECEIVING GASTRIC ELECTRICAL STIMULATION (GES) BEYOND 3 YEARS BY PRESENTING PER PROTOCOL ANALYSIS AND INTENTION-TO-TREAT (ITT) ANALYSIS. ONE PATIENT DEVELOPED A SKIN INFECTION. THE NEUROSTIMULATOR WAS INITIALLY POSITIONED IN THE SUBCUTANEOUS POCKET WITHOUT BEING SUTURED SECURELY ENOUGH TO THE FASCIA. IT PUSHED UP AGAINST THE SKIN IN THIS THIN PATIENT DURING PHYSICAL ACTIVITY, EVENTUALLY CAUSING SKIN PENETRATION. THE INFECTION DID NOT RESPOND TO ANTIBIOTICS. THE DEVICE WAS REMOVED AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA THERAPY LNQ MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention