![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Boston Scientific Issues Alert Over Fatal Pacemaker Incident
Boston Scientific Issues Alert Over Fatal Pacemaker Incident
Boston Scientific sent out an alert when one of its pacemakers, the S-ICD device, “delivered an atypical amount of energy” after environmental radiation corrupted its memory, preventing S-ICD arrhythmia detection/treatment and ultimately causing the patient’s death.
Following the incident, the company conducted a three-week internal investigation and concluded the incident was a “single event upset” with a 1 in 300,000 probability of reoccurring. Despite this finding, Boston Scientific is preparing a software update to safeguard against memory corruption.
Upcoming Events
-
21Oct