BEUDAMED
    FDA Recall Terminated

    Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

    Recall: Z-0088-2010 · Initiated August 25, 2009

    Recall

    Recall Number
    Z-0088-2010
    Event Number
    53086
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LNQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 25, 2009
    Posted
    October 29, 2009
    Terminated
    May 22, 2012
    Address
    7000 Central Ave NE, Minneapolis, MN, 55432-3568

    Description

    Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

    Reason

    Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the bowel associated with Enterra Therapy System leads. Of the 15 reported events, 11 required surgical intervention (all patients recovered withou

    Action

    Medtronic Neuromodulation issued a "Medical Device Correction" letter beginning August 25, 2009 addressed to Healthcare Professionals. The letter described the Nature of the Issue, Scope, Potential Severity of the Issue, Enterra Therapy System labeling updating information warnings, Recommendations and other Additional Information. For further information, contact Medronic Neuromodulation Technical Services at 1-800-707-0933.

    Distribution

    Worldwide Distribution.

    Quantity

    1909 (1095 US, 814 OUS)