Events

Rappel de Device Recall Ascenda Intrathecal Catheter

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
    68295
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1723-2014
  • Date de mise en oeuvre de l'événement
    2014-05-02
  • Date de publication de l'événement
    2014-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127290
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Cause
    Medtronic has determined that an ascenda catheter kit may have had endotoxin in excess of usp limits.
  • Action
    There was only one consignee affected by the recall. The consignee was contacted by phone on 5/2/14 and the information was provided verbally. General Manager & Vice President, Pain Stimulation/Targeted Drug Delivery spoke via phone with the physician managing the patient. The following information was provided: "Medtronic identified the potential for endotoxin levels exceeding USP requirements on product recently implanted (Model 8780, serial number N457062003). "There may be the potential for serious patient injury due to endotoxin within the first hours after implant. "Medtronic recommends observing the patient for symptoms of meningitis. Also to be aware that CSF would not test with a positive culture because endotoxin induced meningitis results in an aseptic meningitis. The physician expressed confidence in the management of the patient and stated he was calling the nursing care facility to increase monitoring of the patient. Subsequent information was received regarding the patient indicating there were no signs of an endotoxin reaction.

Device

Device Recall Ascenda Intrathecal Catheter
  • Modèle / numéro de série
    N457062003
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the state of CT.
  • Description du dispositif
    Medtronic Model 8780 Ascenda Intrathecal Catheter. || The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.
  • 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