Performance Note: Potential for no output/no telemetry condition in subset of IPG and CRT-P products due to ceramic capacitor leakage pathway
Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ CRT-P
Original Date of Communication:
STATUS UPDATE - NOVEMBER 2021
As of 8 November 2021, there have been a total of 21 confirmed events worldwide associated with this failure mode. No additional deaths, beyond the two deaths previously disclosed*, have been reported. Confirmed events included reports of no output, premature depletion and electrical reset that reverted to VVI 65 operation. The range of events have occurred between 2 and 28 months post-implant.
Medtronic’s ongoing monitoring of these failures have allowed us to improve long-term modeling projections for future device failures. The overall projected lifetime rate of occurrence for the remaining active devices manufactured with the original low voltage capacitor is projected to be 0.026%.
All products in distribution are unaffected. The specific low voltage capacitor susceptible to this issue was last used in manufacturing 01 June 2019. Patient management recommendations remain unchanged from the original posting (refer to the May 2019 text below).
*Assessment for cause of death determined loss of pacing therapy could not be ruled out as a contributing factor.
ORIGINAL COMMUNICATION - MAY 2019
Medtronic 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.
As of April 26, 2019, three complaints out of ~266,700 devices distributed worldwide since February 2017, have been received that included a no output /no telemetry scenario resulting from rapid battery depletion. Battery depletion due to this 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, Medtronic expects few, if any, additional events to occur. Medtronic, in consultation with our 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. Pay attention to any unexpected changes in remaining longevity estimates or the inability to interrogate the device and/or transmit data.
Contact Medtronic Technical Services if you have concerns on a specific patient.
Brady Technical Services |firstname.lastname@example.org| 800-505-4636