Events

Retiro De Equipo (Recall) de Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A.

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, Inc. - 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
    Recall
  • ID del evento
    57024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0335-2011
  • Fecha de publicación del evento
    2010-11-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95196
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Causa
    Medtronic is recalling specific lots of model 8731sc intrathecal catheter kits and model 8598a intrathecal catheter spinal revision kits because there is the potential that the 11.4 cm introducer needles within these kits may exceed usp requirements for bacterial endotoxin.
  • Acción
    Medtronica sent an "Urgent: Medical Device Recall" letter, dated September 2010, was sent to medical facilities/customers beginning September 29, 2010. The letter described the issue, identified affected product, requested that unused inventory be segregated and returned to Medtronic Neuromodulation per the enclosed Product Return Instructions form. A Recall Reply Card was also asked to be returned. Additionally an "Urgent: Medical Device Recall" letter was addressed to Healthcare Providers/customers to inform them of the recall of the Catheter and Revision Kits, identified patients by means of registration information, Informed them of the issue with the needle inside the kits, and requested they stop using the specific lots and to monitor any patients for symptoms. If you have any questions or comments, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A.
  • Modelo / Serial
    Lot No.: 0203951576, 0203961984, 0203967623, 0203968380, 0203972121, 0203975643, 0203975644, 0203977013, 0203986903, 0203986904, 0203986905, 0203986906, 0203986907, 0203986908, 0203987226, 0203987613, 0203987614, 0203987927, 0203992275, 0203994418, 0204000009, 0204008277, 0204013891, 0204013892, 0204013893, 0204021022, 0204025158, 0204032708, 0204036999, 0204077467, 0204086950, 0204086951, 0204086952, 0204086953, 0204093420, 0204100469, 0204100472, 0204106116, 0204127318, 0204128817, 0204133515, 0204133516, 0204133517, 0204133545, 0204133546, 0204133547, 0204135762, 0204135763, 0204150859, 0204151516, 0204151517, 0204152813, 0204153722, 0204164696, 0204168597, N258157001, N258157002, N258157003, N258157004, N258157005, N258158001, N258158002, N258158003, N258158004, N258158005, N258158006, N258158007, N258158008, N258158009, N258158010, N258158011, N258158012, N258158013, N258158014, N258158015, N258162001, N258162002, N258162003, N258162004, N258162005, N258162006, N258162007, N258162008, N258162009, N258162010, N258163001, N258163002, N258163003, N258163004, N258163005, N258320001, N258320002, N258320003, N258320004, N258320005, N258327001, N258327002, N258327003, N258327004, N258327005, N258327006, N258327007, N258327008, N258327009, N258327010, N258327011, N258327012, N258327013, N258327014, N258327015, N258329001, N258329002, N258329003, N258329004, N258329005, N258329006, N258329007, N258329008, N258329009, N258329010, N258329011, N258329012, N258329013, N258329014, N258329015, N258329016, N258329017, N258329018, N258329019, N258329020, N258330001, N258330002, N258330003, N258330004, N258330005, N258981001, N258981002, N258981003, N258981004, N258981005, N258981006, N258981007, N258981008, N258981009, N258981010, N258981011, N258981012, N258981013, N258981014, N258981015, N258985001, N258985002, N258985003, N258985004, N258985005, N258985006, N258985007, N258985008, N258985009, N258985010, N258985011, N258985012, N258985013, N258985014, N258985015, N259066001, N259066002, N259066003, N259066004, N259066005, N259425001, N259425002, N259425003, N259425004, N259425005, N259425006, N259425007, N259425008, N259425009, N259425010, N259898001, N259898002, N259898003, N259898004, N259898005, N259898006, N259898007, N259898008, N259898009, N259898010, N259898011, N259900001, N259900002, N259900003, N259900004, N260559001, N260560001, N260560002, N260560003, N260560004, N260560005, N260560006, N260560007, N260560008, N260560009, N260560010, N260560011, N260560012, N260560013, N260560014, N260941001, N260941002, N260941003, N260941004, N260941005, N260946001, N260946002, N260946003, N260946004, N260946005, N260946006, N260946007, N260946008, N260946009, N260946010, N261572001, N261572002, N261572003, N261572004, N261572005, N261572006, N261572007, N261572008, N261572009, N261572010, N261572011, N261572012, N261572013, N261572014, N261572015, N262484001, N262484002, N262484003, N262484004, N262484005, N262484006, N262484007, N262484008, N262484009, N262484010, N262484011, N262484012, N262484013, N262484014, N262484015, N263403001, N263403002, N263403003, N263403004, N263403005, N263403006, N263403007, N263403008, N263403009, N263405001, N263405002, N263405003, N263405004, N263405005, N263405006, N263408001, N263893001, N263893002, N263893003, N263893004, N263893005, N263893006, N263893007, N263893008, N263893009, N263893010, N263893011, N263893012, N263893013, N263893014, N263895001, N263895002, N263895003, N263895004, N263895005, N263895006, N263895007, N263895008, N263895009, N263895010, N263895011, N263895012, N263895013, N263895014, N263895015, N264167001, N264167002, N264167003, N264167004, N264167005, N264167006, N264167007, N264167008, N264167009, N264167010, N264167011, N264167012, N264167013, N264167014, N264167015, N265426001, N265426002, N265426003, N265426004, N265426005, N265426006, N265426007, N265426008, N265426009, N265426010, N265426011, N265426012, N265426013, N265426014, N265426015, N265429001, N265429002, N265429003, N265429004, N265429005, N265429006, N265429007, N265429008, N265429009, N265429010, N265429011, N265429012, N265429013, N265429014, N265429015, N265940001, N265940002, N265940003, N265940004, N265940005, N265940006, N265940007, N265940008, N265940009, N265940010, N268412001, N268412002, N268412003, N268412004, N268412005, N268415001, N268415002, N268415003, N268415004, N268415005, N268415006, N268415007, N268415008, N268415009, N268415010, N268415011, N268415012, N268415013, N268415014, N268415015, N268416001, N268416002, N268416003, N268416004, N268416005, N268416006, N268416007, N268416008, N268416009, N268416010, N268416011, N268416012, N268416013, N268416014, N268416015, N268417001, N268417002, N268417003, N268417004, N268417005, N268417006, N268417007, N268417008, N268417009, N268417010, N268417011, N268417012, N268417013, N268417014, N268417015, N268419001, N268419002, N268419003, N268419004, N268419005, N268424001, N268424002, N268424003, N268424004, N268424005, N268424006, N268424007, N268424008, N268424009, N268424010.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    AL, CA, CO, CT, FL, GA, HI, ID. IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, WY. OUS to include: Argentina, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, San Marino, Jordan, Lithuania, Netherlands, Norway, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, United Arab Emirates, United Kingdom.
  • Descripción del producto
    Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Medtronic Model 8598A Spinal Segment Revision Kit is used when a revision to the spinal segment of a Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port. || To deliver parenteral drugs to the intrathecal space. The needle is used to facilitate the placement of the catheter. The needle is inserted percutaneously into the intrathecal. The needle stylet is then removed to confirm the needle placement through observing backflow of cerebrospinal fluid (CSF) through the needle. The needle stylet prevents tissue coring and also minimizes loss of CSF. The spinal segment tip of the catheter is inserted through the needle until the catheter is advanced to the desired location. Once the catheter position is verified through fluoroscopy, the needle is carefully removed and discarded.
  • Manufacturer
    Medtronic, Inc. - Neuromodulation

Manufacturer

Medtronic, Inc. - Neuromodulation
  • Dirección del fabricante
    Medtronic, Inc. - Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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