Events

Retiro De Equipo (Recall) de Device Recall CONTAK RENEWAL 3 RF & 4 RF

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
    34860
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0863-06
  • Fecha de inicio del evento
    2006-03-11
  • Fecha de publicación del evento
    2006-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44837
  • 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
    Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
  • Acción
    Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up.

Device

Device Recall CONTAK RENEWAL 3 RF & 4 RF
  • Modelo / Serial
    Issue affecting devices is a pre-implant issue. Serial number ranges listed below may also include devices not affected (i.e. implanted devices).  Model H210 serial number 200031 thru 202462.  Model H215 serial numbers 700016 thru 702646.  Model H217 serial numbers 700006 thru 702543.  Model H219 serial numbers 200021 thru 201747.  Model H230 serial numbers 100012 thru 200526.  Model H235 serial numbers 100018 thru 650559.  Model H239 serial numbers 100018 thru 650272.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
  • Descripción del producto
    CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation

Manufacturer

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