Events

Retiro De Equipo (Recall) de Evera ICD

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 Medtronic Inc., Cardiac Rhythm and Heart Failure.

¿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
    74923
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2651-2016
  • Fecha de inicio del evento
    2016-08-12
  • Fecha de publicación del evento
    2016-08-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148795
  • 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
    78 viva crt -ds and evera icds that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. there have been seven (7) confirmed failures (9%) through july 16, 2016. reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
  • Acción
    Consignees were sent or hand delivered on August 12, 2016 a Medtronic "Urgent Medical Device Correction" letter dated August 2016. The letter was addressed to Physician. The letter described the problem and the devices involved in the recall. The letter described a number of "Patient Management Recommendations". For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Device

Evera ICD
  • Modelo / Serial
    Product Name: Evera XT DR lCD. Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1. Serial Numbers:  BWC202738H, BWC202754H, BWB202998H, BWB203157H, BWB203167H, BWB203173H, BWB203186H, BWE601558S, BWE601571S, BWE601578S, BWE601579S, BWE601581S, BWE601589S, BWE601591S, BWE601594S, BWE601600S, BWE601605S, BWD602122S.  Product Name: Evera S DR lCD. Models: DDBC3D1, DDBC3D4. Serial Numbers:  BWG600597S, BWF600969S, BWF600970S, BWF600972S, BWF600973S, BWF600975S, BWF600977S, BWF600978S, BWF600979S, BWF600983S, BWF600984S, BWF600985S, BWF600987S, BWF600989S, BWF600991S, BWF600992S, BWF600996S, BWF601001S.  Product Name: Evera XT VR lCD. Models: DVBB1D1, DVBB2D4. Serial Numbers:  BWI201423H, BWI201436H, BW1201440H, BWI201451H, BWI201454H, BWI201462H, BWI201473H, BWJ601102S, BWJ601108S, BWJ601112S, BWJ601479S, BWJ601101S, BWJ601103S, BWJ601106S.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.
  • Descripción del producto
    Medtronic, Evera Implantable Cardioverter Defibrillators: || Product Model || EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. || EVERA S DDBC3D1, DDBC3D4 || Product Usage: || The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • Dirección del fabricante
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA