Alerta De Seguridad para Emblem S-ICD Systems

Safety alert

2017-01-18

2017-01-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170118b.html

Medical device safety alert: boston scientific emblem s-icd systems medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its emblem subcutaneous implantable cardioverter defibrillator (s-icd) systems [s-icd programmer model 3200]. according to the manufacturer, the model 3200 s-icd programmer is a non-implantable, tablet computer that communicates wirelessly (telemetry) with an implanted s-icd in order to adjust programmable settings and to collect patient data. both the programmer and the s-icd check the validity of telemetry commands using an algorithm intended to detect whether these commands have been altered. in nearly all instances, invalid commands are rejected. in rare instances, interference may go undetected and alter communications from the programmer. this can potentially result in the s-icd performing an induction, utilizing temporary parameters that impair the s-icd from detecting or treating a tachyarrhythmia during the active telemetry session, or disabling therapy in the permanent programming mode such that therapy will be unavailable after the telemetry session is ended. according to the manufacturer, the behaviour is not related to a cybersecurity vulnerability. the potential for this behavior to occur during this brief re-interrogation is extremely remote. there have been no reports of permanent injury or death associated with this behavior. the manufacturer is developing software to mitigate this behavior. until a software update is available, the manufacturer recommends the additional precautions listed in the field safety notice. 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 18 january 2017.