Medtronic Inc. informs about the potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate
4. oktober 2019,
Opdateret 28. oktober 2020
Denne meddelelse indeholder information om fejl i software med instruktion om opdatering og anvendelse af udstyret. Læs mere i meddelelsen fra fabrikanten.
Referencer
- Produkt: CareLink™ 2090 Programmers; CareLink Encore™ 29901 Programmers; CareLink SmartSync™ Device Managers;
Astra/Azure single- and dual-chamber MR Conditional implantable pacemaker generators; Claria MRI™, Amplia
MRI™, Compia MRI™ CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and
SureScan Technology; Evera™ Implantable Cardioverter-Defibrillator (ICD) Devices; Evera MRI SureScan
Implantable Cardioverter Defibrillator; Micra Transcatheter Leadless Pacemaker system; Percepta™, Serena™,
Solara™ implantable cardiac pacemakers with cardiac resynchronization therapy (CRT-P) and SureScan
Technology; Primo MRI™ and Mirro MRI™ SureScan™ Implantable Cardioverter-Defibrillator (ICD); Visia AF™ and
Visia AF MRI™ SureScan™ Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD); Viva™ and Brava™
Cardiac Resynchronization Therapy-Defibrillation (CRT-D) Devices - Fabrikant: Medtronic Inc.
- Fabrikantens referencenummer: FA887
- Lægemiddelstyrelsens sagsnummer: 2019100900