FDAFDA · Alimentos y medicamentos·N.º oficial Z-1123-2022
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Publicado el 1 de junio de 2022 · Inicio del retiro: 30 de marzo de 2022
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
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Neuromodulation
- Distribuidor
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, Netherlands, Belgium, United Kingdom, Japan, Finland, Portugal, Spain, Canary Islands, Denmark, Germany, Switzerland, Ireland, Croatia, Norway.
- Lote
- Model 977006 1) GTIN/UPN: 00763000518615: Expiration Date: 03/14/2023; Serial Numbers: NMS500202H, NMS500236H, NMS500243H, NMS500248H, NMS500253H, NMS500261H, NMS500262H, NMS500265H, NMS500266H, NMS500267H, NMS500269H, NMS500270H, NMS500271H, NMS500272H, NMS500273H, NMS500274H, NMS500275H, NMS500276H, NMS500277H, NMS500278H, NMS500279H, NMS500280H, NMS500282H, NMS500283H, NMS500285H, NMS500286H, NMS500287H, NMS500288H, NMS500289H, NMS500291H, NMS500292H, NMS500293H, NMS500294H, NMS500295H, NMS500296H, NMS500297H, NMS500298H, NMS500299H, NMS500300H, NMS500301H, NMS500302H, NMS500303H, NMS500304H, NMS500305H, NMS500306H, NMS500307H, NMS500308H Expiration Date: 04/14/2023; Serial Numbers: NMS500493H, NMS500494H, NMS500495H, NMS500496H, NMS500497H, NMS500498H, NMS500499H, NMS500500H, NMS500501H, NMS500502H, NMS500503H, NMS500504H, NMS500505H, NMS500506H, NMS500507H, NMS500508H, NMS500509H, NMS500510H, NMS500511H, NMS500512H Expiration Date: 09/14/2023; Serial Numbers: NMS501860H, NMS501861H, NMS501862H, NMS501863H, NMS501864H, NMS501865H, NMS501866H, NMS501923H, NMS501925H, NMS501926H, NMS501931H, NMS502075H, NMS502076H, NMS502079H, NMS502080H, NMS502083H Expiration Date: 09/28/2023; Serial Numbers: NMS502212H, NMS502215H, NMS502220H Expiration Date: 10/14/2023; Serial Numbers:NMS502474H, NMS502476H, NMS502477H, NMS502478H, NMS502479H, NMS502481H, NMS502482H, NMS502483H, NMS502484H, NMS502530H, NMS502531H, NMS502595H, NMS502596H, NMS502597H, NMS502598H, Expiration Date: 10/28/2023; Serial Number: NMS502726H Expiration Date: 11/28/2023; Serial Numbers: NMS503047H, NMS503048H, NMS503049H, NMS503050H, NMS503051H, NMS503052H, NMS503053H, NMS503055H, NMS503056H, NMS503057H, NMS503058H Expiration Date: 12/14/2023; Serial Numbers: NMS503250H, NMS503252H, NMS503257H, NMS503266H, NMS503267H 2) GTIN/UPN: 00763000478087: Expiration Date: 02/28/2023; Serial Numbers: NMS500093H, NMS500094H, NMS500095H, NMS500097H, NMS500098H, NMS500099H, NMS500100H, NMS500101H, NMS500102H, NMS500103H, NMS500104H, NMS500105H, NMS500106H, NMS500107H, NMS500108H, NMS500109H, NMS500110H, NMS500111H, NMS500112H, NMS500113H, NMS500115H, NMS500116H, NMS500117H, NMS500118H, NMS500119H Expiration Date: 03/14/2023; Serial Numbers: NMS500121H, NMS500124H, NMS500125H, NMS500126H, NMS500127H, NMS500128H, NMS500129H, NMS500131H, NMS500132H, NMS500133H, NMS500134H, NMS500136H, NMS500137H, NMS500138H, NMS500139H, NMS500140H, NMS500141H, NMS500142H, NMS500143H, NMS500144H, NMS500145H, NMS500146H, NMS500147H, NMS500148H, NMS500149H, NMS500150H, NMS500151H, NMS500152H, NMS500153H, NMS500154H, NMS500155H, NMS500156H, NMS500157H, NMS500158H, NMS500160H, NMS500161H, NMS500162H, NMS500163H, NMS500164H, NMS500165H, NMS500166H, NMS500167H, NMS500168H, NMS500169H, NMS500170H, NMS500171H, NMS500172H, NMS500173H, NMS500174H, NMS500175H, NMS500176H, NMS500177H, NMS500178H, NMS500179H, NMS500181H, NMS500182H, NMS500183H, NMS500184H, NMS500185H, NMS500186H, NMS500187H, NMS500188H, NMS500189H, NMS500192H, NMS500193H, NMS500195H, NMS500196H, NMS500197H, NMS500198H, NMS500199H, NMS500200H, NMS500203H, NMS500204H, NMS500205H, NMS500206H, NMS500207H, NMS500208H, NMS500209H, NMS500210H, NMS500211H, NMS500212H, NMS500213H, NMS500215H, NMS500216H, NMS500217H, NMS500218H, NMS500219H, NMS500220H, NMS500221H, NMS500222H, NMS500223H, NMS500224H, NMS500225H, NMS500226H, NMS500227H, NMS500228H, NMS500229H, NMS500230H, NMS500231H, NMS500232H, NMS500233H, NMS500234H, NMS500235H, NMS500237H, NMS500238H, NMS500239H, NMS500241H, NMS500242H, NMS500244H, NMS500245H, NMS500246H, NMS500247H, NMS500249H, NMS500250H, NMS500251H, NMS500252H, NMS500254H, NMS500255H, NMS500256H, NMS500257H, NMS500258H, NMS500259H, NMS500260H, NMS500263H, NMS500264H Expiration Date: 07/28/2023; Serial Number: NMS501474H Expiration Date: 08/14/2023; Serial Numbers: NMS501602H, NMS501606H Expiration Date: 08/28/2023; Serial Numbers: NMS501610H, NMS501611H, NMS501613H, NMS501617H, NMS501618H, NMS501632H, NMS501633
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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