The Medicines and Healthcare products Regulatory Agency(MHRA), United Kingdom posted a field safety notice concerning Accent SR and Accent DR pacemakers, manufactured by St. Jude Medical.
The manufacturer has identified that a subset of Accent SR single chamber model PM1110 and Accent DR dual chamber model PM2112 pacemakers will not provide a change in sensor driven (rate responsive) pacing rates in response to patient physical activity due to an incorrect software setting. In devices programmed to a rate-responsive mode, the pacemaker will function in a basic programmed mode and will not provide a sensor driven rate increase when the patient is physically active. All other programmed parameters, features and functions operate as designed, e.g. an Accent DR device programmed to DDDR will appropriately track atrial activity and properly function in the DDD mode.
According to the manufacturer, recall of the unimplanted products is on-going. The manufacturer advises healthcare professionals to:
Furthermore, according to the manufacturer, a non-invasive programmer software solution will be developed and once it is available, the sensor anomaly can be automatically corrected at follow up by a simple interrogation of the pacemaker. Follow up of patients exhibiting clinical symptoms due to the lack of increased pacing rates with exercise should be prioritized.
According to local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON213146
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 11 December 2012