Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

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   Model Number: 3660 UDI-DI Codes: 05415067031419 05415067020192 Serial Numbers: US AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1 AAD222.1 AAD230.1 AAD232.1 AAD235.1 AAD240.1 AAD241.1 AAD246.1 AAD248.1 AAD252.1 AAD260.1 AAD268.1 AAD269.1 AAD274.1 AAD282.1 AAD284.1 AAD286.1 AAD291.1 AAD292.1 AAD303.1 AAD304.1 AAD305.1 AAD306.1 AAD311.1 AAD312.1 AAD317.1 AAD321.1 AAD334.1 AAD337.1 AAD341.1 AAD343.1 AAD358.1 AAD361.1 AAD363.1 AAD364.1 AAD366.1 AAD369.1 AAD370.1 AAD374.1 AAD378.1 AAD382.1 AAN928.1 AAN929.1 AAN930.1 AAN931.1 AAN932.1 AAN935.1 AAN937.1 AAN942.1 AAN945.1 AAN949.1 AAN950.1 AAN956.1 AAN961.1 AAN966.1 AAN967.1 AAN972.1 AAN978.1 AAN979.1 AAN983.1 AAN985.1 AAN986.1 AAN992.1 AAN994.1 AAN999.1 AAP002.1 AAP003.1 AAP012.1 AAP021.1 AAP027.1 AAP037.1 AAP039.1 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 AAP087.1 AAP091.1 AAP098.1 AAP101.1 AAP105.1 AAP110.1 AAP112.1 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AGN108.1 AGN109.1 AGN112.1 AGN113.1 AGN118.1 AGN119.1 AGN120.1 AGN122.1 AGN123.1 AGN124.1 AGN125.1 AGN127.1 AGN131.1 AGN135.1 AGN138.1 AGN139.1 AGN141.1 AGN145.1 AGN146.1 AGN147.1 AGN148.1 AGN151.1 AGN152.1 AGN153.1 AGN154.1 AGN159.1 AGN163.1 AGN169.1 AGN174.1 AGN177.1 AGN179.1 AGN180.1 AGN181.1 AGN182.1 AGN187.1 AGN191.1 AGN193.1 AGN194.1 AGN196.1 AGN197.1 AGN200.1 AGN204.1 AGN210.1 AGN212.1 AGN213.1 AGN217.1 AGN218.1 AGN221.1 AGN226.1 AGN228.1 AGN233.1 AGN234.1 AGN241.1 AGN242.1 AGN246.1 AGN248.1 AGN254.1 AGN257.1 AGN258.1 AGN261.1 AGN264.1 AGN267.1 AGN269.1 AGN272.1 AGN274.1 AGN275.1 AGN277.1 AGN278.1 AGN287.1 AGN289.1 AGN292.1 AGN297.1 AGN298.1 AGN301.1 AGN304.1 AGN312.1 AGN313.1 AGN317.1 AGN318.1 AGN319.1 AGN321.1 AGN329.1 AGN330.1 AGN333.1 AGN334.1 AGN342.1 AGN345.1 AGN346.1 AGN351.1 AGN353.1 AGN356.1 AGN359.1 AGN366.1 AGN367.1 AGN368.1 AGN370.1 AGN372.1 AGN373.1 AGN379.1 AGN380.1 AGN382.1 AGN386.1 AGN388.1 AGN392.1 AGN397.1 AGN398.1 AGN401.1 AGN402.1 AGN403.1 AGN405.1 AGN407.1 AGN408.1 AGN411.1 AGN412.1 AGN413.1 AGN414.1 AGN415.1 AGN417.1 AGN422.1 AGN424.1 AGN427.1 AGN428.1 AGN431.1 AGN432.1 AGN439.1 AGN441.1 AGN442.1 AGN443.1 AGN444.1 AGN445.1 AGN446.1 AGN451.1 AGN453.1 AGN455.1 AGN457.1 AGN458.1 AGN464.1 AGN471.1 AGN472.1 AGN475.1 AGN481.1 AGN482.1 AGN483.1 AGN484.1 AGN486.1 AGN487.1 AGN488.1 AGN489.1 AGN491.1 AGN492.1 AGN496.1 AGN497.1 AGN498.1 AGN499.1 AGN501.1 AGN505.1 AGN507.1 AGN511.1 AGN513.1 AGN515.1 AGN517.1 AGN519.1 AGN521.1 AGN524.1 AGN525.1 AGN527.1 AGN529.1 AGN530.1 AGN531.1 AGN533.1 AGN534.1 AGN537.1 AGN539.1 AGN540.1 AGN543.1 AGN544.1 AGN548.1 AGN556.1 AGN557.1 AGN558.1 AGN561.1 AGN563.1 AGN564.1 AGN566.1 AGN568.1 AGN569.1 AGN570.1 AGN571.1 AGN574.1 AGN575.1 AGN577.1 AGN578.1 AGN579.1 AGN581.1 AGN585.1 AGN589.1 AGN590.1 AGN591.1 AGN593.1 AGN594.1 AGN597.1 AGN599.1 AGN602.1 AGN604.1 AGN606.1 AGN607.1 AGN608.1 AGN610.1 AGN611.1 AGN613.1 AGN615.1 AGN622.1 AGU276.1 AGU282.1 AGU285.1 AGU288.1 AGU289.1 AGU292.1 AGU296.1 AGU297.1 AGU304.1 AGU306.1 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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.