CARDIOVASCULAR
hamburger

HEARTMATE II™ LVAD REPORTED ICD EXPERIENCE

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.

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

Epic™-HF V-350

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™

Atlas-HF™ V-340

St. Jude Medical™

Atlas-HF™ V-341

St. Jude Medical™

Atlas-HF™ V-343

St. Jude Medical™

SN V-235

St. Jude Medical™

Unify Quadra 3251 40Q

Sorin Group

Alto 2 model 624

Sorin Group

Paradigm

HEARTMATE 3™ LVAD REPORTED ICD EXPERIENCE

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

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?

true
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?