Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) ...

Product Description

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).

Reason for Recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Lot / Code Information

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 AAP123.1 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AFZ866.1 AFZ869.1 AFZ871.1 AFZ873.1 AFZ874.1 AFZ878.1 AFZ888.1 AFZ894.1 AFZ895.1 AFZ900.1 AFZ902.1 AFZ905.1 AFZ909.1 AFZ917.1 AFZ922.1 AFZ924.1 AFZ928.1 AFZ942.1 AFZ955.1 AFZ956.1 AFZ958.1 AFZ959.1 AFZ961.1 AFZ964.1 AFZ965.1 AFZ976.1 AFZ985.1 AFZ986.1 AFZ987.1 AFZ990.1 AFZ997.1 AGA011.1 AGA025.1 AGA026.1 AGA033.1 AGA037.1 AGA038.1 AGA041.1 AGA042.1 AGA046.1 AGA054.1 AGA058.1 AGA062.1 AGA065.1 AGA070.1 AGA073.1 AGA077.1 AGA080.1 AGA081.1 AGA082.1 AGA093.1 AGA097.1 AGA099.1 AGA100.1 AGA101.1 AGM575.1 AGM576.1 AGM577.1 AGM579.1 AGM581.1 AGM582.1 AGM597.1 AGM605.1 AGM609.1 AGM615.1 AGM621.1 AGM622.1 AGM630.1 AGM635.1 AGM636.1 AGM639.1 AGM640.1 AGM641.1 AGM648.1 AGM650.1 AGM651.1 AGM652.1 AGM653.1 AGM654.1 AGM661.1 AGM662.1 AGM664.1 AGM666.1 AGM676.1 AGM677.1 AGM680.1 AGM683.1 AGM687.1 AGM688.1 AGM689.1 AGM690.1 AGM692.1 AGM694.1 AGM696.1 AGM697.1 AGM700.1 AGM703.1 AGM706.1 AGM708.1 AGM713.1 AGM714.1 AGM717.1 AGM718.1 AGM719.1 AGM720.1 AGM722.1 AGM723.1 AGM727.1 AGM728.1 AGM729.1 AGM733.1 AGM734.1 AGM735.1 AGM738.1 AGM762.1 AGM767.1 AGM770.1 AGM777.1 AGM779.1 AGM781.1 AGM786.1 AGM792.1 AGM795.1 AGM799.1 AGM800.1 AGM801.1 AGM802.1 AGM807.1 AGM810.1 AGM811.1 AGM812.1 AGM814.1 AGM815.1 AGM817.1 AGM819.1 AGM822.1 AGM829.1 AGM830.1 AGM834.1 AGM836.1 AGM837.1 AGM840.1 AGM847.1 AGM849.1 AGM853.1 AGM861.1 AGM863.1 AGM868.1 AGM869.1 AGM880.1 AGM884.1 AGM887.1 AGM888.1 AGM893.1 AGM894.1 AGM895.1 AGM899.1 AGM908.1 AGM910.1 AGM911.1 AGM920.1 AGM922.1 AGM923.1 AGM929.1 AGM930.1 AGM933.1 AGM935.1 AGM936.1 AGM943.1 AGM947.1 AGM948.1 AGM949.1 AGM961.1 AGM962.1 AGM963.1 AGM966.1 AGM967.1 AGM968.1 AGM975.1 AGM976.1 AGM977.1 AGM979.1 AGM980.1 AGM981.1 AGM984.1 AGM986.1 AGM987.1 AGM990.1 AGM994.1 AGN014.1 AGN015.1 AGN023.1 AGN025.1 AGN028.1 AGN037.1 AGN039.1 AGN043.1 AGN044.1 AGN045.1 AGN048.1 AGN049.1 AGN050.1 AGN051.1 AGN053.1 AGN059.1 AGN060.1 AGN063.1 AGN072.1 AGN076.1 AGN078.1 AGN083.1 AGN084.1 AGN085.1 AGN086.1 AGN092.1 AGN094.1 AGN096.1 AGN097.1 AGN099.1 AGN101.1 AGN107.1 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 AGU308.1 AGU312.1 AGU317.1 AGU320.1 AGU321.1 AGU324.1 AGU325.1 AGU326.1 AGU327.1 AGU331.1 AGU333.1 AGU335.1 AGU338.1 AGU341.1 AGU342.1 AGU345.1 AGU346.1 AGU347.1 AGU349.1 AGU350.1 AGU351.1 AGU355.1 AGU360.1 AGU361.1 AGU363.1 AGU364.1 AGU366.1 AGU368.1 AGU369.1 AGU370.1 AGU372.1 AGU374.1 AGU375.1 AGU376.1 AGU377.1 AGU378.1 AGU379.1 AGU381.1 AGU386.1 AGU387.1 AGU388.1 AGU389.1 AGU390.1 AGU393.1 AGU394.1 AGU396.1 AGU398.1 AGU401.1 AGU402.1 AGU404.1 AGU409.1 AGU410.1 AGU413.1 AGU415.1 AGU416.1 AGU417.1 AGU421.1 AGU422.1 AGU424.1 AGU427.1 AGU428.1 AGU429.1 AGU430.1 AGU431.1 AGU432.1 AGU433.1 AGU434.1 AGU435.1 AGU438.1 AGU439.1 AGU440.1 AGU444.1 AHD570.1 AHD574.1 AHD579.1 AHD581.1 AHD594.1 AHD596.1 AHD602.1 AHD604.1 AHD608.1 AHD609.1 AHD611.1 AHD614.1 AHD615.1 AHD616.1 AHD620.1 AHD623.1 AHD624.1 AHD625.1 AHD627.1 AHD628.1 AHD629.1 AHD630.1 AHD632.1 AHD634.1 AHD636.1 AHD637.1 AHD638.1 AHD639.1 AHD640.1 AHD641.1 AHD643.1 AHD645.1 AHD647.1 AHD650.1 AHD651.1 AHD652.1 AHD653.1 AHD656.1 AHD659.1 AHD665.1 AHD667.1 AHD688.1 AHD691.1 AHD697.1 AHD699.1 AHD700.1 AHD702.1 AHD703.1 AHD706.1 AHD708.1 AHD716.1 AHD717.1 AHD721.1 AHD723.1 AHD728.1 AHD731.1 AHD732.1 AHD734.1 AHD738.1 AHD740.1 AHD741.1 AHD746.1 AHD747.1 AHD754.1 AHD762.1 AHD771.1 AHD773.1 AHD774.1 AHD777.1 AHD778.1 AHD782.1 AHD802.1 AHD804.1 AHD811.1 AHD812.1 AHD813.1 AHD815.1 AHD820.1 AHD824.1 AHD826.1 AHD828.1 AHD831.1 AHD833.1 AHD834.1 AHD838.1 AHD843.1 AHD844.1 AHD850.1 AHD853.1 AHD855.1 AHD856.1 AHD859.1 AHD862.1 AHD863.1 AHD868.1 AHD874.1 AHD886.1 AHK481.1 AHK487.1 AHK494.1 AHK496.1 AHK499.1 AHK500.1 AHK501.1 AHK502.1 AHK523.1 AHK525.1 AHK535.1 AHK550.1 AHK558.1 AHK571.1 AHK580.1 AHK598.1 AHK600.1 AHK602.1 AHK606.1 AHK607.1 AHK630.1 AHK631.1 AHK640.1 AHK648.1 AHK650.1 AHK654.1 AHK662.1 AHK671.1 AHK674.1 AHK675.1 AHK678.1 AHK691.1 AHK696.1 AHK702.1 AHK708.1 AHK716.1 AHK721.1 AHK723.1 AHK728.1 AHK730.1 AHK740.1 AHK749.1 AHK753.1 AHK758.1 AHK759.1 AHK760.1 AHK766.1 AHK776.1 AHK780.1 AHK799.1 AHK815.1 AHK832.1 AHK840.1 AHK843.1 AHK855.1 AHK858.1 AHK859.1 AHK861.1 AHK862.1 AHK865.1 AHK867.1 AHK871.1 AHK872.1 AHK873.1 AHK878.1 AHK880.1 AHK882.1 AHK887.1 AHK889.1 AHK894.1 AHK896.1 AHK901.1 AHK904.1 AHK907.1 AHK910.1 AHK911.1 AHK913.1 AHK914.1 AHK919.1 AHK924.1 AHK925.1 AHK927.1 AHK930.1 AHK932.1 AHK933.1 AHK945.1 AHK956.1 AHK960.1 AHK963.1 AHK964.1 AHK966.1 AHK974.1 AHK980.1 AHK981.1 AHK982.1 AHK985.1 AHK987.1 AHK989.1 AHK991.1 AHK995.1 AHK996.1 AHL003.1 AHL009.1 AHL014.1 AHL017.1 AHL021.1 AHL026.1 AHL029.1 AHL030.1 AHL040.1 AHL041.1 AHL043.1 AHL044.1 AHL045.1 AHL048.1 AHL052.1 AHL055.1 AHL057.1 AHL059.1 AHL061.1 AHL062.1 AHL063.1 AHL067.1 AHL068.1 A

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