Events

Rappel de Device Recall SynchroMed EL implantable infusion pump

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
    63712
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0496-2013
  • Date de mise en oeuvre de l'événement
    2012-11-09
  • Date de publication de l'événement
    2012-12-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114597
  • 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 notified healthcare professionals of the impact of unapproved drugs on the performance of the synchromed infusion pump system. use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. update 2/1/2016: medtronic received approval to incorporate enhancements to the synchromed ii pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
  • Action
    The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST. UPDATE 2/1/2016: Medtronic began notifying consignees 2/1/2016 via, mail, telephone and/or in person visit by a Medtronic Field Representative. The Medtronic Field Representatives will retrieve devices in the US and provide an Urgent Medical Device Removal letter. The letter states that device design has been updated and the Medtronic Field Representative has retrieved any devices with a Use By date on or before 5/14/2017. An account specific Customer Confirmation Form was to be completed by either the Medtronic Field Representative or the consignee. Consignees with questions can contatct their Medtronic Field Representative, or Customer Service at 1-888-854-0978.

Device

Device Recall SynchroMed EL implantable infusion pump
  • Modèle / numéro de série
    All SynchroMed EL and SynchroMed II pumps
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
  • Description du dispositif
    SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.
  • 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