HeartMate II

Left Ventricular Assist Device

HeartMate II LVAD Reported ICD Experience

The clinical 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™ LVAD. 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 LVAD 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:

ManufacturerModel No.
AbbottAltas™ model V-193
AbbottAtlas™ model V-242
AbbottAtlas™ model V-243
AbbottAtlas™ model V-366
AbbottAtlas-HF™ model V-340
AbbottAtlas-HF™ model V-341
AbbottAtlas-HF™ model V-343
AbbottAtlas™ VR model V-199
AbbottCurrent™ DR RF 2207-36
AbbottCurrent™ RF VR 1207-36
AbbottEpic™ HF CRT-D model V-337
AbbottEpic™ HF CRT-D model V-338
AbbottEpic™ HF model V-350
AbbottEpic™ Plus VR model V-196
AbbottIntegrity™ SR model 5142
AbbottPhoton™ Micron DR model V-232
AbbottPromote™ RF CRT-D model 3207-36
AbbottQuadra Assura™ MP model 3371-40QC
AbbottSN model V-235
AbbottUnify Quadra™ model 3251 40Q
Sorin GroupAlto 2 model 624
Sorin GroupParadigm

MAT-2011428 v2.0