Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Dual Chamber Pacemakers. The devices are identified as follow:
The manufacturer informed the users of a voluntary recall and distribution suspension affecting a subset of Medtronic dual chamber pacemakers distributed worldwide between 10 Mar 2017 and 7 Jan 2019 under the brand names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series. (Not all devices within these brand names are affected by this recall).
According to the manufacturer, the subset of dual chamber pacemakers has the potential to experience a circuit error during a unique sequence of events when programmed to a dual chamber mode with atrial sensing which may cause a pause in pacing therapy.
The manufacturer estimates that on average, a device in a susceptible pacing mode has a 2.8% chance per month of experiencing a pacing pause of 1.5 seconds or longer. Risk is minimised in patients who have an escape rhythm adequate to prevent syncope during a loss of ventricular pacing, since a ventricular-sensed event restores full device functionality. No risk of a pause due to this circuit error exists for patients programmed to a non-susceptible pacing mode.
Through 4 Jan 2019, the manufacturer is aware of four reported occurrences in two patients where a pause in pacing therapy was clinically apparent due to this circuit error. These reported events occurred in three devices from a total of 156,957 devices sold worldwide. No deaths have been reported as a result of the issue.
The manufacturer is developing a software update that can be installed into affected devices to correct this issue. Until that time, the manufacturer is providing the patient management recommendations described in the customer and physician letters.
Affected customers are advised to segregate and remove all unused affected products from the inventory and return all unused affected product to the manufacturer.
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 18 January 2019