Events

Retiro De Equipo (Recall) de Device Recall Deep Brain Stimulation (DBS") Lead Kits

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 Neuromodulation.

¿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
    49446
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0184-2009
  • Fecha de inicio del evento
    2008-06-14
  • Fecha de publicación del evento
    2008-10-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73342
  • 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
    Lead - Product Code MHY
  • Causa
    Medtronic has received reports of dbs" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. the lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d.
  • Acción
    Consignees were sent a "Medtronic Urgent: Medical Device Correction" letter 8/2008. The letter addressed to Healthcare Professionals, described the product involved, explanation of the issue, recommendations for Implant and included an attachment "Updated Instructions for Using the Lead Cap". Contact Medtronic Neuromodulation at 1-800-707-0933 for assistance.

Device

Device Recall Deep Brain Stimulation (DBS") Lead Kits
  • Modelo / Serial
    PIN # 3387S0000V
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    AL, AZ, AR, CA, CO, CT, FL, DC, GA, HI, ID, IL , IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE , NV, NH, NJ, NM, NY, NC, ND, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI. ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROATIA, CYPRESS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, LUXEMBOURG, MEXICO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. || Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145 || Implant manual: DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. || Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Dirección del fabricante
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA