⚠️Product defect correction / Implant hazard alert ⚠️ Boston Scientific have advised that a subset of ACCOLADE dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps) have an increased risk of permanently entering Safety Mode which has limited functionality. The following products have been affected: Affected Model numbers: L311, L331, U225, U226, U228 Product Names: • ACCOLADE DR SL MRI • ACCOLADE DR EL MRI • VISIONIST CRT-P EL • VISIONIST CRT-P EL MRI The affected devices are at risk of permanently entering Safety Mode during telemetry or other normal, higher-power operations. This has been associated with the pacemaker failing to adequately regulate the heart’s rhythm and rate in some patients. Health professionals are advised to: • Monitor patients with affected pacemakers through remote or in-person visits. • When a device is in Safety Mode, you will be directed to contact Boston Scientific via the LATITUDE programmer warning screen and a LATITUDE remote patient management system red alert. • Monitor patients for symptoms indicating device performance problems, such as light-headedness or loss of consciousness. • General prophylactic device replacement is not recommended: unless a patient has a device in the advisory population and are at risk of harm due to non-programmable parameters in Safety Mode. • If monitoring indicates that the device has entered Safety Mode, arrange for the device to be replaced. Timely replacement is recommended to avoid risks associated with time spent in Safety Mode. • Detailed information can be found in the customer letter supplied to clinicians who have implanted this device. Read more: https://lnkd.in/giZ6Zsvg
