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HeartMate II™ LVAD Reported ICD Experience

HeartMate II™ LVAD Reported ICD Experience

The clinical trial experience indicates that certain models of implantable cardiac defibrillators (ICDs) and certain implantable pace makers (IPMs) may, in some cases, not be able to establish telemetry and be reprogrammed due to electromagnetic interference when used with the HeartMate II. 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.
St. Jude Medical™Atlas-HF™ V-340
St. Jude Medical™Atlas-HF™ V-341
St. Jude Medical™Atlas-HF™ V-343
St. Jude Medical™Atlas™ V193
St. Jude Medical™Atlas™ V-242
St. Jude Medical™Atlas™ V-243
St. Jude Medical™Atlas™ V-366
St. Jude Medical™Atlas™ VR model V-199
St. Jude Medical™Current™ DR RF 2207-36
St. Jude Medical™Current™ RF VR 1207-36
St. Jude Medical™Epic™ HF CRT-D model V-337
St. Jude Medical™Epic™ HF CRT-D model V-338
St. Jude Medical™Epic™-HF V-350
St. Jude Medical™Epic™ Plus VR model V-196
St. Jude Medical™Integrity™SR 5142
St. Jude Medical™Photon™ Micron DR model V-232
St. Jude Medical™Promote™ RF CRT-D model 3207-36
St. Jude Medical™SN V-235
St. Jude Medical™Unify Quadra 3251 40Q
Sorin GroupAlto 2 model 624
Sorin GroupParadigm