Events

Alerta De Seguridad para RELIANCE 4-FRONT

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

¿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
    2015-05-22
  • Fecha de publicación del evento
    2015-05-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150522a.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: boston scientific reliance 4-front medical device manufacturer, boston scientific, has issued a medical device safety alert concerning reliance 4-front. the affected devices are identified as follows:- model numbers: 1) 0682; 2) 0692 serial numbers: 1) 121478, 121502, 121485, 121503, 121488, 121504, 121489, 121505, 121490, 121506, 121491, 121507, 121494, 121509, 121495, 121510, 121497, 121511, 121501, 121514; 2) 121454, 121466, 121481, 121516, 121527, 121455, 121467, 121482, 121517, 121528, 121456, 121468, 121483, 121519, 121530, 121458, 121469, 121484, 121520, 121531, 121459, 121470, 121487, 121521, 121532, 121460, 121472, 121492, 121522, 121533, 121461, 121473, 121493, 121523, 121534, 121462, 121475, 121496, 121524, 121538, 121463, 121476, 121508, 121525, 121540, 121464, 121477, 121515, 121526, 121541, 121465, 121479 according to the manufacturer, one lead of a subset of seventy-two boston scientific reliance 4-fronttm single coil defibrillation leads distributed in europe and japan exhibited intermittent high pacing impedance and oversensing at implant. laboratory analysis determined that the terminal ring for the distal shock electrode was not fully connected to the conductor cable. further investigation determined that manufacturing equipment used to attach the terminal ring to the conductor cable was slightly offset from the intended position for a short period of time. the seventy-two leads were manufactured during this offset period, and may have a terminal ring that was not fully connected to the conductor cable. if the terminal ring is not securely connected to the conductor cable, potential clinical symptoms may include high or intermittently high pacing or shock lead impedance, noisy electrograms (egms) (particularly during pocket manipulation), or sensing anomalies that could affect either pacing pulses or shocks. a terminal ring that is not fully connected to the conductor cable could cause clinical symptoms during the replacement procedure. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 may 2015.

Device

RELIANCE 4-FRONT
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific RELIANCE 4-FRONT
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH