Events

Retiro De Equipo (Recall) de Device Recall SSeries Headpiece Short Range

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 LLC.

¿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
    50204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0959-2009
  • Fecha de inicio del evento
    2008-07-24
  • Fecha de publicación del evento
    2009-02-03
  • 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=77303
  • 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
    cochlear implant - Product Code MCM
  • Causa
    Mistuned headpiece - advanced bionics recently became aware of a tuning issue with some platinum series and s-series headpieces shipped from may 2007 through april 2008. tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. potential clinical symptoms include: -no lock -intermittent lock -implant locks, but cann.
  • Acción
    Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the number of headpiece-related complaints, firm advises of the potential clinical symptoms: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps. Per the letter, as long as the system maintains lock, there is no degradation in sound quality or stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal. Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.

Device

Device Recall SSeries Headpiece Short Range
  • Modelo / Serial
    a) Model MMT-5300-00 (beige); Serial Numbers:14122, 14124, 14125, 14126, 14127, 14128, 14129, 14130, 14132, 14133, 14134, 14135, 14137, 14138, 14139, 14141, 14142, 14143, 14144, 14145, 14147, 14148, 14149, 14150, 14151, 14152, 14153, 14155, 14156, 14157, 14158, 14159, 14160, 14161, 14162, 14163, 14164, 14166, 14168, 14169, 14170, 14171, 14715, 14716, 14717, 14718, 14719, 14720, 14721, 14722, 14723, 14724, 14725, 14726, 14727, 14730, 14732, 14735, 14736, 14741, 14742, 14743, 14800, 14955, 14956, 14964, 14971, 15105, 15106, 15107, 15110, 15111, 15112, 15117, 15118 and 15120.   b) Model MMT-5300-10 (brown); Serial Numbers: 10250, 10251, 10252, 10254, 10255, 10256, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10306, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10316, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10326, 10327, 10328, 10329, 10330, 10331, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10340, 10341, 10342, 10344, 10345, 10346, 10348, 10352, 10354, 10362, 10367, 10374, 10375, 10378, 10559, 10561, 10566, 10572, 10573, 10577, 10578, 10582, 10583, 10586, 10587, 10588, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10656, 10657, 10658, 10659, 10660, 10661, 10663, 10664, 10665, 10666, 10668, 10669, 10670, 10673, 10674, 10675, 10676, 10677, 10678, 10682, 10684, 10702, 10705, 10769, 10770, 10771, 10773 and 10774.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide
  • Descripción del producto
    S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
  • Manufacturer
    Advanced Bionics LLC

Manufacturer

Advanced Bionics LLC
  • Dirección del fabricante
    Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Empresa matriz del fabricante (2017)
    Sonova Holding Ag
  • Source
    USFDA