Events

Retiro De Equipo (Recall) de COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific Pty Ltd.

¿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
    RC-2013-RN-00906-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00906-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Boston scientific has determined that the performance of a low voltage capacitor in a subset of cognis crt-ds and teligen icds manufactured prior to december 2009 may be compromised over time, causing increased current drain that can lead to premature battery depletion. all cases reported to date have been detected by diagnostic tools within boston scientific’s safety architecture before device function was compromised. “safety architecture” refers to a set of diagnostic monitoring which periodically assess device performance, including battery voltage, power consumption, and charge time, and have proven effective in identifying instances of unexpected battery use (via programmer alert screens or replacement indicators) before therapy becomes unavailable.
  • Acción
    There are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring. - Remind patients to contact the clinic if beeping is heard from their device, as instructed in the patient manual. - Physicians should promptly investigate alerts and unanticipated replacement indicator messages. - Following a Safety Architecture alert, contact Boston Scientific Technical Services as directed on programmer screens [24 hours per day / 7 days per week]. Technical Services can facilitate an evaluation of “save-to-disk” information (while the device is still implanted) to help clarify available replacement time. For more details, see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130903.htm .

Device

COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR ...
  • Modelo / Serial
    COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)Affected model numbers: COGNIS CRT-D : N106, N107, N118, N119, P106, P107TELIGEN DR ICD: E110, F110TELIGEN VR ICD: E102, F102Manufactured prior to December 2009ARTG Numbers: 154034, 154033, 154039 & 154037
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA