Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

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   Gallant: Model Number: HF CRT-D REF CDHFA500Q UDI-DI Code: 05415067032010 Serial Numbers: 111023714 111033397 111026077 111008528 810007304 810023031 111009077 810007164 111036262 111026540 111013180 810020124 111040419 111042048 810022176 111029687 111006406 111017718 810008795 111012956 111016597 810022867 810018823 810006029 810027443 810000072 810016983 111011034 111015410 810006013 111009628 111018199 111030383 810026178 111037835 111038995 111039205 111039169 111039213 111039103 111039227 111039172 111039154 111039298 111038919 111040351 111037720 111037178 111037142 111005031 810019888 810007234 111028528 111001728 111001715 111000681 111000233 111000202 111000235 111001707 111001777 111000294 111015428 111000224 111000494 111016493 111015792 111001752 111001687 111021218 111021101 111009661 111010339 111010612 111010599 111010615 111036821 111043197 111037844 111014472 111005935 111014496 111006045 111006001 111016094 810027416 810000369 810003198 111028551 111028566 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2. Do not eat it: Even if it looks and smells fine, do not consume this product.
3. Throw it away or return it: You can return the product to the store for a full refund.
4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
5. Report problems: Report any issues to the FDA's Safety Reporting Portal.