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
    48761
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2380-2008
  • Date de mise en oeuvre de l'événement
    2008-06-26
  • Date de publication de l'événement
    2008-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72070
  • 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
    Disconnection of the medtronic sutureless connector (sc) catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump.
  • Action
    Medtronic sent A Safety Alert dated June 2008, on June 27, 2008, to healthcare professionals, which described the issues of occlusion and disconnect. The letter identifies the affected catheter and revision kit model numbers and the associated implantable infusion pumps. The issues do not involve Medtronic MiniMed insulin pump. The letter refers the HCP to recommendations for Implant Techniques and Recommendations for Patency Verification that are included with the letter. The letter also includes recommendations for managing patients with implanted SC catheters.

Device

Device Recall Medtronic INDURA 1P Intrathecal Catheter
  • Modèle / numéro de série
    All SC Catheters
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA, Puerto Rico, Algeria, Aruba, Austria, Australia, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 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 (2), Anchors (4).
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Adresse du fabricant
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA