Device Recall Activa PC

  • Modèle / numéro de série
    Serial numbers: NKM724776H, NKM724782H, NKM724785H,  NKM724790H, NKM724802H, NKM724843H.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of: MA, NC, OH, and TX.
  • Description du dispositif
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. || The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Neuromodulation, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • Société-mère du fabricant (2017)
  • 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

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  • Modèle / numéro de série
    The first released affected product was released to the market in April, 2005.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution - all states including DC and Puerto Rico.
  • Description du dispositif
    Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
  • Manufacturer