Events

Rappel de Device Recall Enterra Gastric Electrical Stimulation System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Neuromodulation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53086
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0088-2010
  • Date de mise en oeuvre de l'événement
    2009-08-25
  • Date de publication de l'événement
    2009-10-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84612
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Intestinal stimulator - Product Code LNQ
  • Cause
    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.

Device

Device Recall Enterra Gastric Electrical Stimulation System
  • Modèle / numéro de série
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    HDE
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    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.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Adresse du fabricant
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA