Uploaded on Apr 22, 2024
The high incidence of clinical adverse events attributed especially to high-risk medical devices has led to an advocated change from many stakeholders. This is especially true with respect to devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality due to their frequent use in older populations with frequent co-morbidities. For instance, in July 2023, Medtronic plc (Ireland) recalled their Implantable Cardioverter Defibrillators (ICDs) Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with glassed feedthrough for risk of low or no energy output during high voltage therapy. The reason for this recall was the failure of the devices to deliver low or no energy output, which can fail to correct arrhythmias, leading to cardiac arrest, other serious injuries, or death.
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