Events

Retiro De Equipo (Recall) de CONTAK RENEWAL 4

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 Guidant 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
    33716
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0891-06
  • Fecha de publicación del evento
    2006-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42341
  • 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
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
  • Causa
    Devices manufactured with batteries built on april 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
  • Acción
    Guidant issued a Physicain letter, dated 10/25/05 to implanting/following physicians. The letter states the issues and reommends patient follow-up care every three months, as stated in published labeling. An Advisory Update, dated 12/20/05, was sent to physicians that describes the issue, states that here have been zero reports of battery weld failures on implanted devices and the results of laboratory testing (accelerated testing) in which they tried to induce the failure. The results of the testing induced 2 battery weld post failures. A projected rate of occurence was also given. Patient management recommendations have not changed.

Device

CONTAK RENEWAL 4
  • Modelo / Serial
    Model H190, serial numbers: 310258, 310260, 310293, 310312, 310317, 310319, 310320, 310321, 310322, 310343,  310353, 310355, 310381, 310383, 310386, 310387, 310388,  310389, 310390.   Model H195, serial numbers: 350236, 350239, 350245,  350247, 350248, 350250, 350252, 350255, 350261, 350264,  350276, 350279, 350280, 350282, 350284, 350319, 350330,  350331, 350332, 350333, 350334, 350336, 350342, 350344,  350350, 350351, 350353, 350354, 350355, 350360, 350362,  350363, 350364, 350365, 350403, 350407, 350442, 350451,  350480, 350484, 350503, 350570, 350649.  Model H199, serial numbers: 320330, 320331, 320361, 320366, 320370, 320415, 320417, 320445.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide (AL, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI). OUS to include: Australia, France, Germany, India, Ireland, Israel, Italy, Netherlands, Norway, South Africa, Spain, Switzerland, Turkey, United Kingdom.
  • Descripción del producto
    CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Dirección del fabricante
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA