Events

Retiro De Equipo (Recall) de Device Recall CONTAK RENEWAL 3 & 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
    35537
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1192-06
  • Fecha de inicio del evento
    2006-05-15
  • Fecha de publicación del evento
    2006-07-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46350
  • 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 has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). repetitive mechanical stress in this orientation can result in loss of shock therapy, loss of pacing therapy (intermittent or permanent), loss of telemetry, programmer warning screen upon interrogation, and beeping.
  • Acción
    The recall was initiated on May 15, 2006, with a press release and a letter to physicians. Physicians are asked to review the specific positioning of each device for patients implanted with affected models. This is a review of medical records to determine if the device is subpectoral. Then use of an AP radiograph on patients with a subpectoral implant to determine device orientation and if leads exit in a clockwise direction. In those cases, it''s recommended physicians advise the patient of the potential for failure, and follow-up at least once per quarter per device labeling and consider device replacement for larger muscle/active patients or for patients who regularly utilize therapy. Physicians are instructed to orient device with the serial number facing away from the ribs for future implants.

Device

Device Recall CONTAK RENEWAL 3 & 4
  • Modelo / Serial
    Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Guidant.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Polynesia, Portugal, Qatar, Russia, Saint Lucia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, West Indies.
  • Descripción del producto
    Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Dirección del fabricante
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA