FDA MedWatch - INGENIO Family of Pacemakers and CRT-Ps by Boston Scientific:

Class I Recall - Due to Risk of Incorrect Transition to Safety Mode

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: INGENIO Family of Pacemakers and CRT-Ps by Boston Scientific: Class I Recall - Due to Risk of Incorrect Transition to Safety Mode AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of incorrect transition to safety mode. Safety mode is intended to provide backup if the device is faulty. However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device incorrectly goes into safety mode, the device cannot be reprogrammed and must be replaced. The use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death. There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Boston Scientific INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) are devices used with patients who have low heart rates, and patients with moderate to severe heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. RECOMMENDATIONS:  On June 3, 2021, Boston Scientific sent all affected customers an Important Medical Device Advisory. The letter requested customers to: When assessing potential risk for a patient if their device incorrectly transitions to safety mode, consider patient-specific factors (which may vary over time), including underlying health issues, pacemaker dependence, or problems with pacing. If a device incorrectly enters safety mode, schedule replacement. Boston Scientific does not recommend preventive replacement for affected devices. However, for individual patients, factors such as those listed above in the previous bullet and shared decision-making may support consideration of early device replacement to prevent unintended outcomes. In these cases, the following guidance should be considered: For EL pacemakers, if early replacement is planned, schedule replacement when the service life of the device is four years (or less, if the device currently indicates fewer than four years remaining). For CRT-Ps, if early replacement is planned, schedule replacement when the service life of the device remaining is three years (or less, if the device currently indicates fewer than three years remaining). Perform a system follow-up remotely or in person at least every 12 months. For patients who may not require early device replacement, continue with existing follow-up procedures until there is one year of service life expected and then follow-up every three months until replacement (as indicated in the device's instructions for use). For each patient with an affected device, add the Boston Scientific INGENIO EL Pacemakers and CRT-Ps Physician Letter sent on June 3, 2021 to their medical record to maintain awareness of this topic for the remaining service life of the device. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA