Events

Alerta De Seguridad para RestoreSensor Implantable Neurostimulators

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-04-29
  • Fecha de publicación del evento
    2016-04-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160429.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic restoresensor implantable neurostimulators medical device manufacturer, medtronic, has issued a medical device safety alert concerning its restoresensor multi-program rechargeable neurostimulator and medtronic restoresensor surescan mri [product codes: 37714 and 97714] the manufacturer has confirmed four instances of loss of therapy during recharging of a restoresensor implantable neurostimulator, for a rate of 0.007% of devices distributed worldwide. by design, stimulation therapy turns off when battery voltage depletes below 3.575 volts. in the reported occurrences, a charging session was terminated prior to obtaining a recharge threshold voltage of 3.615, which triggered a rapid battery depletion state. as a result of the rapid battery discharge state, the implanted neurostimulators depleted to 1.925 volts (a state of overdischarge) in one to two days rather than the typical 30 days. according to the manufacturer, insufficient coupling (charging efficiency) between the recharger and the implanted neurostimulator during the recharge session was found to be a key factor in the reported events. once a device is in the over discharge state, therapy is interrupted with return of patient symptoms and can only be restored using the physician recharge mode of the recharger. as described in labeling, if three occurrences of overdischarge occur, the neurostimulator will trigger end of life, and must be replaced to restore therapy. affected users are advised to follow current recharge instructions, paying particular attention to charging efficiency and battery charge level indicators on the recharger. check the neurostimulator battery charge level once a day or more frequently as needed. keep the neurostimulator sufficiently charged to maintain therapy. it can be charged at any time; do not need to wait for a low battery message. during neurostimulator recharging, monitor the charging efficiency row and adjust the antenna to obtain as many solid black boxes as possible. if only two boxes are filled in (6 or more boxes are empty) adjust the antenna to improve the signal strength between the neurostimulator and recharger. during recharging, ensure the neurostimulator battery charge level is at least 25% before ending the charge session. however, a full battery charge is ideal. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 april 2016.

Device

RestoreSensor Implantable Neurostimulators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic RestoreSensor Implantable Neurostimulators
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH