Retiro De Equipo (Recall) de Device Recall Kinetra Implantable Neurostimulator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Neuromodulation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Neurostimulator - Product Code MHY
  • Causa
    Cessation of therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.
  • Acción
    A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.


  • Modelo / Serial
    NFD100921H, NFD100922H, NFD100924H, NFD100925H, NFD100926H, NFD100928H, NFD100930H, NFD100931H, NFD100932H, NFD100939H, NFD100940H, NFD100941H, NFD100943H, NFD100944H, NFD100945H, NFD100946H, NFD100947H, NFD100948H, NFD100949H, NFD100950H, NFD100951H, NFD100952H, NFD100960H, NFD100961H, NFD100963H, NFD100964H, NFD100965H, NFD100966H, NFD100967H, NFD100968H, NFD100969H, NFD100970H, NFD100971H, NFD100974H, NFD100978H, NFD100980H, NFD100982H, NFD100983H, NFD100985H, NFD100986H, NFD100996H, NFD100997H, NFD100998H, NFD100999H, NFD101000H, NFD101002H, NFD101003H, NFD101005H, NFD101006H, NFD101007H, NFD101008H, NFD101009H, NFD101010H, NFD101011H, NFD101012H, NFD101013H, NFD101014H, NFD101015H, NFD101017H, NFD101018H, NFD101020H, NFD101021H, NFD101023H, NFD101024H, NFD101025H, NFD101026H, NFD101027H, NFD101028H, NFD101030H, NFD101031H, NFD101033H, NFD101035H, NFD101036H, NFD101037H, NFD101038H, NFD101040H, NFD101041H, NFD101042H, NFD101043H, NFD101044H, NFD101045H, NFD101046H, NFD101047H, 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NFD627695S, NFD627696S, NFD627697S, NFD627698S.NFD627699S, NFD627700S, NFD627701S, NFD627702S, NFD627703S, NFD627704S, NFD627707S, NFD627708S, NFD627709S, NFD627710S, NFD627711S, NFD627712S, NFD627713S, NFD627714S, NFD627715S, NFD627716S, NFD627717S, NFD627718S, NFD627719S, NFD627720S, NFD627721S, NFD627722S, NFD627723S, NFD627724S, NFD627725S, NFD627726S, NFD627727S, NFD627728S, NFD627729S, NFD627730S, NFD627731S, NFD627732S, NFD627733S, NFD627734S, NFD627735S, NFD627736S, NFD627737S, NFD627738S, NFD627739S, NFD627740S, NFD627741S, NFD627742S, NFD627743S, NFD627744S, NFD627745S, NFD627746S, NFD627747S, NFD627748S, NFD627749S, NFD627750S, NFD627751S, NFD627752S, NFD627753S, NFD627754S, NFD627755S, NFD627756S, NFD627757S, NFD627758S, NFD627759S, NFD627760S, NFD627761S, NFD627762S, NFD627763S, NFD627764S, NFD627765S, NFD627766S, NFD627767S, NFD627768S, NFD627769S, NFD627770S, NFD627771S, NFD627773S, NFD627774S, NFD627775S, NFD627776S, NFD627777S, NFD627778S, NFD627779S, NFD627780S, NFD627781S, NFD627782S, NFD627783S, NFD627784S, NFD627785S, NFD627786S, NFD627787S, NFD627788S, NFD627789S, NFD627790S, NFD627791S, NFD627793S, NFD627794S, NFD627795S, NFD627796S, NFD627797S, NFD627798S, NFD627799S, NFD627800S, NFD627801S, NFD627802S, NFD627803S, NFD627804S, NFD627805S, NFD627806S, NFD627807S, NFD627808S, NFD627809S, NFD627810S, NFD627811S, NFD627812S, NFD627813S, NFD627814S, NFD627815S, NFD627816S, NFD627817S, NFD627818S, NFD627819S, NFD627820S, NFD627821S, NFD627822S, NFD627823S, NFD627824S, NFD627825S, NFD627826S, NFD627827S, NFD627828S, NFD627829S, NFD627830S, NFD627831S, NFD627832S, NFD627833S, NFD627835S, NFD627836S, NFD627837S, NFD627838S, NFD627839S, NFD627840S, NFD627841S, NFD627842S, NFD627843S, NFD627845S, NFD627846S, NFD627847S, NFD627848S, NFD627850S, NFD627851S, NFD627852S, NFD627853S, NFD627854S, NFD627855S, NFD627856S, NFD627857S, NFD627858S, NFD627859S, NFD627860S, NFD627861S, NFD627862S, NFD627863S, NFD627864S, NFD627865S, NFD627866S, NFD627867S, NFD627868S, NFD627869S, NFD627870S, NFD627871S, NFD627872S, NFD627873S, NFD627874S, NFD627875S, NFD627876S, NFD627877S, NFD627878S, NFD627879S, NFD627880S, NFD627881S, NFD627882S, NFD627883S, NFD627884S, NFD627885S, NFD627886S, NFD627887S, NFD627888S, NFD627889S, NFD627890S, NFD627891S, NFD627892S, NFD627893S, NFD627894S, NFD627895S, NFD627896S, NFD627897S, NFD627898S, NFD627899S, NFD627900S, NFD627901S, NFD627902S, NFD627903S, NFD627904S, NFD627905S, NFD627906S, NFD627907S, NFD627908S, NFD627909S, NFD627910S, NFD627911S, NFD627912S, NFD627913S, NFD627914S, NFD627915S, NFD627916S, NFD627917S, NFD627918S, NFD627919S, NFD627920S, NFD627921S, NFD627922S, NFD627923S, NFD627924S, NFD627925S, NFD627926S, NFD627927S, NFD627928S, NFD627929S, NFD627930S, NFD627931S, NFD627932S, NFD627933S, NFD627934S, NFD627935S, NFD627936S, NFD627937S, NFD627938S, NFD627939S, NFD627940S, NFD627941S, NFD627942S, NFD627943S, NFD627944S, NFD627945S, NFD627946S, NFD627947S, NFD627948S, NFD627949S, NFD627950S, NFD627951S, NFD627952S, NFD627953S, NFD627954S, NFD627955S, NFD627956S, NFD627957S, NFD627958S, NFD627959S, NFD627960S, NFD627962S, NFD627965S, NFD627966S, NFD627968S, NFD627969S, NFD627970S, NFD627971S, NFD627973S, NFD627974S, NFD627975S, NFD627976S, NFD627977S, NFD627979S, NFD627981S, NFD627982S, NFD627983S, NFD627984S, NFD627985S, NFD627986S, NFD627987S, NFD627988S, NFD627989S, NFD627990S, NFD627993S, NFD627994S, NFD627996S, NFD627997S, NFD627998S, NFD628000S, NFD628001S, NFD628002S, NFD628003S, NFD628004S, NFD628005S, NFD628006S, NFD628007S, NFD628008S, NFD628009S, NFD628010S, NFD628011S, NFD628012S, NFD628014S, NFD628015S, NFD628016S, NFD628017S, NFD628019S, NFD628021S, NFD628022S, NFD628023S, NFD628024S, NFD628027S, NFD628028S, NFD628030S, NFD628031S, NFD628036S, NFD628039S, NFD628042S, NFD628043S, NFD628044S, NFD628046S, NFD628053S, NFD628055S, NFD628056S, NFD628057S, NFD628059S, NFD628061S, NFD628063S, NFD628074S, NFD628076S, NFD628079S, NFD628080S, NFD628082S, NFD628085S, NFD628086S, NFD628089S, NFD628092S, NFD628094S, NFD628102S, NFD628103S, NFD628109S, NFD628110S, NFD628114S, NFD628116S, NFD628120S, NFD628122S, NFD628125S, NFD628128S, NFD628129S, NFD628130S, NFD628131S, NFD628133S, NFD628134S, NFD628148S, NFD628153S, NFD628188S, NFD628191S, NFD628192S, NFD628195S, NFD628196S, NFD628197S, NFD628205S, NFD628207S, NFD628208S, NFD628210S, NFD628275S, NFD628283S, NFD628284S, NFD628286S, NFD628292S, NFD628293S, NFD628296S, NFD628298S, NFD628299S, NFD628300S, NFD628301S, NFD628304S, NFD628305S, NFD628306S, NFD628307S, NFD628308S, NFD628311S, NFD628312S, NFD628314S, NFD628315S, NFD628316S, NFD628320S, NFD628322S, NFD628323S, NFD628324S, NFD628325S, NFD628326S, NFD628327S, NFD628328S, NFD628329S, NFD628330S, NFD628331S, NFD628332S, NFD628333S, NFD628334S, NFD628335S, NFD628336S, NFD628337S, NFD628338S, NFD628339S, NFD628340S, NFD628342S, NFD628343S, NFD628344S, NFD628346S, NFD628347S, NFD628348S, NFD628349S, NFD628350S, NFD628351S, NFD628353S, NFD628354S, NFD628355S, NFD628357S, NFD628359S, NFD628362S, NFD628364S, NFD628365S, NFD628366S, NFD628367S, NFD628370S, NFD628371S, NFD628377S, NFD628378S, NFD628379S, NFD628383S, NFD628385S, and NFD628386S
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The United Kingdom
  • Descripción del producto
    Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)
  • Manufacturer


  • Dirección del fabricante
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source