Thoratec Corporation - Medical Professionals

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
Sorin Group	Alto 2 model 624