Events

Rappel de Device Recall Medtronic Indura 1P 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
    53129
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2073-2009
  • Date de mise en oeuvre de l'événement
    2009-08-27
  • Date de publication de l'événement
    2009-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84737
  • 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
    Intrathecal Catheter - Product Code LKK
  • Cause
    Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
  • Action
    A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants. A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card. Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".

Device

Device Recall Medtronic Indura 1P Intrathecal Catheter
  • Modèle / numéro de série
    Model 8709SC used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US (including Washington D.C. and Puerto Rico), Algeria, Aruba, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Poland, Portugal, Reunion, Romania, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.
  • Description du dispositif
    Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The implanted infusion system components consist of a Medtronic pump and a model 8709SC Catheter. The catheter connects to the pump at the catheter port. Contents: 81.4-cm Catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6-cm catheter and connector pin, Transparent strain-relief sleeves, Anchors. || This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space.
  • 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