Boston Scientific warns on fluke S-ICD death

Boston Scientific (NYSE:BSX) last month alerted physicians after learning of a fluke incident involving its S-ICD pacemaker, in which a patient died when the device’s memory was corrupted by radiation. In a June letter to physicians, Marlborough, Mass.-based Boston Scientific wrote of “a single, isolated S-ICD event that resulted in a device-related patient death in May of this year.” “Boston Scientific engineers have determined that this patient’s S-ICD repeatedly delivered an atypical amount of energy (similar to the arrhythmia induction function) because a specific memory location was corrupted by radiation within the environment. This repeated atypical energy delivery prevented S-ICD arrhythmia detection/treatment and ultimately contributed to the patient death,” according to the letter, which noted that the radiation involved in the incident was from an ionized subatomic particle such as an alpha particle, neutron, or high energy proton – although it does not appear that the deceased patient received ionizing radiation therapy prior to the event. A three-week internal investigation in the lab, including experiments to simulate the issue, led Boston engineers to conclude that the incident was a one-off – a so-called “single event upset” involving “a change of state in the device memory induced by environmental radiation interacting with a specific memory location,” with a probability of approximately one in...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Wall Street Beat Boston Scientific Cardiac Rhythm Management Source Type: news