Events

Retiro De Equipo (Recall) de Device Recall Advanced Bionics HiRes 90K Cochlear Implant device

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 Advanced Bionics Corporation.

¿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
    57349
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0795-2011
  • Fecha de inicio del evento
    2010-11-23
  • Fecha de publicación del evento
    2010-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95924
  • 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
    Implant, cochlear - Product Code MCM
  • Causa
    The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. these recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
  • Acción
    Advanced Bionics (AB) Personal contacted all centers with known surgeries about the recall by telephone on November 22, 2010, and sent Blastfax to affected surgeons and clinicians. AB forwarding a Press Release on November 23, 2010 to the Business Wire News Trak. The firm also faxed Health Care Provider letters to the affected Health Care Providers and placed a Patient notification letter on the AB website on November 23, 2010. Health Care Provider letters were FedEx'ed November 24, 2010 to the affected Health Care Providers. Patient Letters were sent via FedEx'ed beginning Monday November 29th and 30th to approx. 10,500 patients. A Recall Acknowledgement Form was included for each recipient to sign as proof that the notification has been read. The press release & recall letter informed the patients/consignees of the reason for recall, the product affected and the potential hazard involved. The Health Care Provider letter also requested providers with recipient under their care who reports pain, overly loud sounds, or sudden shock sensations while the implant is powered to follow these steps: 1. Advise them to remove the external equipment immediately, 2. Schedule an appointment to complete standard troubleshooting steps listed in the AB Sound Processor User Guide, 3. If standard troubleshooting does not resolve the issue, please contact Advanced Bionics for additional troubleshooting steps that may assist in determining the presence of recall problem, 4. If your evaluation of the patient's condition suggests that the implant exhibits this problem, device explantation and replacement is advised. In addition, the Health Care Provider letter informed providers that if AB records show that you have any unregistered implants in their possession, a list of serial numbers has been provided for devices that must be returned to Advanced Bionics. If no unregistered implants have been identified, no list will be enclosed. The Patient letter also

Device

Device Recall Advanced Bionics HiRes 90K Cochlear Implant device
  • Modelo / Serial
    Serial Numbers: 316001 315123 315913 316001 316070 318275 319856 320644 320806 321180 321554 321720 322009 322438 322483 322841 323064 323133 323239 323371 323401 323461 323529 323979 324168 324186 324671 324735 324781 324845 324981 325065 325205 325407 325468 325637 325760 325947 326005 326178 326187 326553 326680 326747 326805 326811 326815 326849 326853 326863 326895 327093 327195 327235 327414 327566 327590 327693 327700 327707 327741 327764 327979 327996 328000 328061 328086 328198 328239 328398 328519 328608 329064 329165 329231 329244 329294 329299 329387 329397 329414 329436 329441 329445 329487 329509 329590 329626 329649 329670 329713 329734 329793 329794 329823 329850 329857 329858 329879 329913 329948 329968 329988 330577 330773 330803 402329 402342 402535 402588 402597 402610 402613 402622 402630 402634 402638 402656 402663 402664 402684 402687 402694 402697 402717 402771 402772 402786 402800 402830 402831 402921 402934 402938 402939 402940 402941 402942 402943 402947 402948 402953 402976 402979 402982 402985 402987 402991 402994 403010 403020 403023 403025 403030 403037 403057 403069 403088 403098 403099 403100 403115 403122 403125 403135 403139 403142 403144 403150 403169 403172 403186 403199 403200 403231 403238 403264 403283 403335 403349 403380 403386 403397 403402 403420 403437 403445 403470 403488 403490 403495 403497 403498 403501 403502 403505 403512 403514 403516 403520 403527 403531 403540 403542 403552 403557 403562 403563 403566 403570 403572 403574 403597 403601 403607 403608 403609 403611 403617 403622 403623 403625 403644 403659 403667 403669 403695 403697 403711 403718 403758 403766 403790 403792 403798 403800 403812 403820 403823 403829 403834 403836 403849 403850 403852 403861 403862 403866 403870 403872 403874 403879 403885 403886 403888 403902 403907 403910 403911 403913 403915 403916 403917 403923 403924 403938 403941 403946 403949 403952 403976 403985 403989 403992 403997 404011 404018 404020 404055 404080 404081 404090 404104 404108 404111 404113 404118 404121 404125 404129 404131 404133 404139 404141 404143 404146 404149 404151 404156 404157 404168 404173 404181 404184 404191 404193 404199 404206 404212 404225 404227 404254 404255 404258 404270 404279 404319 404326 404372 404381 404402 404414 404415 404444 404456 404459 404483 404495 404500 404519 404521 404537 404550
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA.
  • Descripción del producto
    Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 || Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
  • Manufacturer
    Advanced Bionics Corporation

Manufacturer

Advanced Bionics Corporation
  • Dirección del fabricante
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA