CARDIOVASCULAR
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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:

 

Manufacturer Model No.
Abbott Altas™ model V-193
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

MAT-2011428 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.