Implantable vagus nerve stimulators (VNS) 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

Premature battery depletion (models 103 and 104).
Inaccurate battery life projection (models 103, 104 and 250).
Loss of therapy (all models).
Painful, erratic or atypical stimulation (all models).The MHRA has issued this Medical Device Alert (MDA) to support Cyberonics’ corrective actions, as it has informed us that to date there has been a low level of response to its Field Safety Notices (FSNs) listed below.In July 2009 Cyberonics issued a FSN concerning Model 250 Programming software when used with Pulse and Pulse Duo Generators (Models 100, 101, 102 & 102R) and Demipulse and Demipulse Duo Generators (Models 103 and 104).In November 2009 Cyberonics issued a FSN concerning the Demipulse and Demipulse Duo Generators (Models 103 and 104).In April 2010 Cyberonics issued a FSN concerning Model 250 Programming software when used with Demipulse and Demipulse Duo Generators (Models 103 and 104).Cyberonics has requested that clinicians contact its team as soon as possible if they should have received any of the above FSNs but did not. It is important to follow the actions advised in FSNs, and for your organisation to acknowledge receipt of FSNs. The receipt provides the manufacturer, and subsequently the MHRA, with the means to monitor the progress of Field Safety Corrective Actions. It also minimises the need for the MHRA to issue MDAs, which otherwise place an additional burden on the health service because of the broadcast nature of the MDA and the extra administrative work required.11 Reporting Adverse Incidents and Disseminating Medical Device Alerts - DB 2010(01)