FDAFDA · Alimentos y medicamentos·N.º oficial Z-1890-2024
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Publicado el 5 de junio de 2024 · Inicio del retiro: 18 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific Neuromodulation Corporation
- Distribuidor
- Worldwide - US Nationwide distribution including in the states of TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV, AL, IL, AR, SC, OK, MO, MS, NJ, ME, Hi, KS, SD, WV, NM, AK, CT, WY, NE, ND and the countries of Canada, Argentina, Chile, Colombia, Brazil, Algeria, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Jordan, Kazakhstan, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Australia, Thailand, Singapore, Hong Kong, Korea, India, Japan.
- Lote
- REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365DB12160/8714729985044/100209 - 753347/09-OCT-2020 through 26-MAR-2026; M365DB12320/8714729985051/100104 - 753200/09-OCT-2020 through 21-MAR-2026
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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