Experience indicates that certain models of implantable cardiac defibrillators (ICDs) and certain implantable pacemakers (IPMs) may, in some cases, not be able to establish telemetry and be reprogrammed due to electromagnetic interference when used with the HeartMate 3™ LVAS.
In such cases the ICDs or IPMs have continued to function properly and only their ability to communicate with the programmer was affected. The HeartMate 3 system complies with applicable electromagnetic compatibility standards and is not influenced by such devices. No such difficulties have been reported with models other than those listed below.
Difficulty or inability to communicate with the ICD or IPM programmer has been reported for or may occur with the following manufacturer families:
| Manufacturer | Family / Model |
|---|---|
| Biotronik | Acticor/Rivacor |
| Biotronik | Ilivia Neo/Intica Neo |
| Biotronik | Ilivia/Intica/Inlexa |
| Biotronik | Itrevia/Iperia/Inventra |
| Biotronik | Iforia/Ilesto/Idova |
| Biotronik | Lumax |
| ELA Medical (Sorin) | Paradyme CRT |
| Medtronic | Cardia CRT |
| Boston Scientific | ORIGEN CRT |
MAT-2012393 v1.0
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