Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Azure and Astra pacemakers, Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P). The affected Models distributed in Hong Kong are identified as the following: W1TR04, W1TR05, W4TR04, W4TR05, X2DR01, X2SR01
The manufacturer has identified a rare but potentially serious failure mode in a population of Azure and Astra pacemakers, and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P), manufactured with a specific multilayer ceramic capacitor. These devices continue to perform within reliability projections.
While inherently very reliable, a known failure mode of these capacitors is the potential for internal cracking that can be caused by thermal-mechanical stress during manufacturing. Under rare conditions, internal cracking within a capacitor may result in the development of a leakage pathway, causing high current drain and leading to rapid battery depletion. While the issue presents as rapid battery depletion, this is not a battery performance issue.
According to the manufacturer, as of 26 Apr 2019, three complaints out of around 266,700 devices distributed worldwide since Feb 2017, have been received that included a no output/no telemetry scenario resulting from rapid battery depletion. Battery depletion due to the issue can range from several days to several weeks. One of these reported events contributed to a patient death. The three confirmed failures occurred within 9 months post implant. The projected rate for this issue is 0.0028%, with the most susceptible period for a leakage pathway to develop in the capacitor being the first 12 months post implant. Based on the low predicted rate of failure and the recent implementation of process and component enhancements, the Manufacturer expects few, if any, additional events to occur.
The manufacturer in consultation with the Independent Physician Quality Panel, does not recommend device replacement. Physicians should continue normal patient follow-up in accordance with standard practice, and where possible, continue to utilize the low battery voltage wireless CareAlert (shipped ON), together with remote monitoring via CareLink home monitor or the MyCareLink Heart mobile app. Per the instructions for use, at each follow-up, verify the status of the implanted system as well as the clinical effectiveness of the device. Users are advised to pay attention to any unexpected changes in remaining longevity estimates or the inability to interrogate the device and/or transmit data.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 10 May 2019