Events

Retiro De Equipo (Recall) de Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. || The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid || the physician''s assessment of a patient''s condition and the performance of the implanted 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 Biotronik Inc.

¿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
    26041
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0817-03
  • Fecha de inicio del evento
    2003-03-21
  • Fecha de publicación del evento
    2003-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26920
  • 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
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Causa
    Potential extended charge time anomalies.
  • Acción
    The firm issued a letter dated 3/21/03 via certified return receipt requested. The envelope and letter are flagged 'IMPORTANT: Patient Management Information'. The letter recommends that physicians schedule an immediate follow-up visit with each of their patients implanted with an affected Belos VR or VR-T ICD to evaluate the device charge times. The firm provided the doctors with the names of their patients.

Device

Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. || Th...
  • Modelo / Serial
    Part number 331135. Serial numbers 78140020, 78140021, 78140026, 78140027, 78140029, 78140035, 78140037, 78140038, 78140039, 78140045, 78140046, 78140048, 78140049, 78140051, 78140052, 78140053, 78140054, 78140055, 78140056, 78140057, 78140058, 78140059, 78140060, 78140061, 78140062, 78140063, 78140064, 78140065, 78140066, 78140067, 78140070, 78140071, 78140072, 78140073, 78140102, 78140103, 78140104, 78140105, 78140109, 78140111, 78140112, 78140113, 78140114, 78140124, 78140132, 78140134, 78140135, 78140136, 78140139
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
  • Descripción del producto
    Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter Defibrillator. || The Belos VR-T is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid || the physician''s assessment of a patient''s condition and the performance of the implanted device.
  • Manufacturer
    Biotronik Inc

Manufacturer

Biotronik Inc
  • Dirección del fabricante
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA