The clinical trial 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 II system. 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 II system complies with all applicable electromagnetic compatibility standards and is not influenced in any way 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 the following manufacturer models:
Manufacturer |
Model No. |
|---|---|
Abbott |
Atlas™ model V193 |
Abbott |
Atlas™ model V-242 |
Abbott |
Atlas™ model V-243 |
Abbott |
Atlas™ model V-366 |
Abbott |
Atlas-HF™ model V-340 |
Abbott |
Atlas-HF™ model V-341 |
Abbott |
Atlas-HF™ model V-343 |
Abbott |
Atlas™ VR model V-199 |
Abbott |
Current™ DR RF 2207-36 |
Abbott |
Current™ RF VR 1207-36 |
Abbott |
Epic™ HF CRT-D model V-337 |
Abbott |
Epic™ HF CRT-D model V-338 |
Abbott |
Epic™ HF model V-350 |
Abbott |
Epic™ Plus VR model V-196 |
Abbott |
Integrity™SR model 5142 |
Abbott |
Photon™ Micron DR model V-232 |
Abbott |
Promote™ RF CRT-D model 3207-36 |
Abbott |
Quadra Assura MP model 3371-40QC |
Abbott |
SN model V-235 |
Abbott |
Unify Quadra model 3251 40Q |
Sorin Group |
Alto 2 model 624 |
Sorin Group |
Paradigm |
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 all applicable electromagnetic compatibility standards and is not influenced in any way 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 the following manufacturer models:
Manufacturer |
Model No. |
|---|---|
Biotronik |
Iforia 5-HF-t |
Biotronik |
Iforia 5-VR-T |
Biotronik |
Iforia CRT-D |
Biotronik |
Ilestro 7-VR-T DX |
Biotronik |
Ilestro 7-HFT-RF |
ELA Medical (Sorin) |
Paradyme RF CRT-D9750 |
SJM-CV WEB-0718-0037a(1)
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