Alerta De Seguridad para Emblem S-ICD System

Safety alert

2017-07-03

2017-07-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170703.html

Medical device safety alert: boston scientific emblem s-icd system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its emblem s-icd system [models: 1010, a209, a219]. the manufacturer informed physicians that a single and isolated s-icd event that resulted in a device-related patient death in may of 2017. the manufacturer’s engineers have determined that the 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. the repeated atypical energy delivery prevented s-icd arrhythmia detection/treatment and ultimately contributed to the patient death. according to the manufacturer, this experience represents one observed event in approximately 37,000 s-icds distributed worldwide. given the rarity of this single event observed to date, a precise projection of occurrence cannot be derived with confidence. engineering analysis of s-icd device memory design and recorded instances of single event upsets (seus) in fielded devices was conducted during the manufacturer’s root cause investigation of this event. based on this analysis, the probability of corruption of the specific location in memory that produces this device behavior within an s-icd was determined to be approximately 1 in 300,000 over five years. although reoccurrence of this device behavior is highly unlikely, the manufacturer is developing software mitigations to prevent this from occurring in the future. it is important to note that this particular device behavior cannot occur with any boston scientific transvenous defibrillators or pacemakers due to differences in hardware and software. until the software mitigation update is available, this s-icd behavior represents an additional, small risk that should be considered when evaluating the relative risks associated with all available icd therapy options. the manufacturer recommends the additional precautions listed in fsn. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 july 2017.