Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description:

Summary

The FDA issued a Class I for Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Procla by Abbott Medical. Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators)..

Details

Product Description

Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) 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).

Lot/Code Info: Model Number: 3662 UDI-DI Codes: 05415067031426 05415067020222 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 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AEJ238.1 AEJ256.1 AEJ258.1 AEJ262.1 AEJ267.1 AEJ268.1 AEJ269.1 AEM740.1 AEM744.1 AEM745.1 AEM752.1 AEM757.1 AEM762.1 AEM772.1 AEM775.1 AEM779.1 AEM787.1 AEM793.1 AEM794.1 AEM800.1 AEM801.1 AEM806.1 AEM811.1 AEM812.1 AEM813.1 AEM815.1 AEM822.1 AEM825.1 AEM831.1 AEM832.1 AEM842.1 AEM846.1 AEM848.1 AEM858.1 AEM859.1 AEM863.1 AEM865.1 AEM866.1 AEM869.1 AEM870.1 AEM878.1 AEM879.1 AEM881.1 AEM884.1 AEM890.1 AEM891.1 AEM905.1 AEM907.1 AEM911.1 AEM914.1 AEM926.1 AEM931.1 AEM935.1 AEM937.1 AEM938.1 AEM939.1 AEM946.1 AEM947.1 AEM955.1 AEM960.1 AEM962.1 AEM966.1 AEM977.1 AEM994.1 AEM999.1 AEN012.1 AEN013.1 AEN017.1 AEN021.1 AEN022.1 AEN026.1 AEN027.1 AEN029.1 AEN030.1 AEN036.1 AEN038.1 AEN043.1 AEN046.1 AEN049.1 AEN052.1 AEN055.1 AEN061.1 AEN064.1 AEN066.1 AEN067.1 AEN070.1 AEN072.1 AEN075.1 AEN078.1 AEN081.1 AEN084.1 AEN085.1 AEN086.1 AEN087.1 AEN092.1 AEN094.1 AEN095.1 AEN096.1 AEN097.1 AEN098.1 AEN100.1 AEN101.1 AEN102.1 AEN104.1 AEN105.1 AEN106.1 AEN107.1 AEN108.1 AEN112.1 AEN113.1 AEN116.1 AEN117.1 AEN118.1 AEN122.1 AEN124.1 AEN127.1 AEN130.1 AEN131.1 AEN134.1 AEN135.1 AEN140.1 AEN145.1 AEN146.1 AEN147.1 AFB226.1 AFB228.1 AFB230.1 AFB234.1 AFB237.1 AFB238.1 AFB239.1 AFB241.1 AFB246.1 AFB247.1 AFB249.1 AFB251.1 AFB252.1 AFB253.1 AFB254.1 AFB257.1 AFB259.1 AFB260.1 AFB262.1 AFB265.1 AFB268.1 AFB269.1 AFB271.1 AFB272.1 AFB276.1 AFB277.1 AFB281.1 AFB285.1 AFB287.1 AFB288.1 AFB291.1 AFB292.1 AFB297.1 AFB300.1 AFB302.1 AFB305.1 AFB306.1 AFB310.1 AFB311.1 AFB312.1 AFB313.1 AFB314.1 AFB315.1 AFB316.1 AFB319.1 AFB320.1 AFB322.1 AFB323.1 AFB324.1 AFB325.1 AFB326.1 AFB327.1 AFB328.1 AFB329.1 AFB331.1 AFB332.1 AFB335.1 AFB336.1 AFB339.1 AFB341.1 AFB344.1 AFB345.1 AFB347.1 AFB351.1 AFB352.1 AFB353.1 AFB354.1 AFB355.1 AFB359.1 AFB360.1 AFB361.1 AFB363.1 AFB366.1 AFB368.1 AFB369.1 AFB372.1 AFB377.1 AFB378.1 AFB379.1 AFB380.1 AFB381.1 AFB383.1 AFB387.1 AFB388.1 AFB389.1 AFB390.1 AFB400.1 AFB416.1 AFB420.1 AFB421.1 AFB423.1 AFB437.1 AFB438.1 AFB443.1 AFB459.1 AFB463.1 AFB464.1 AFB466.1 AFB468.1 AFB469.1 AFB476.1 AFB478.1 AFB480.1 AFB481.1 AFB482.1 AFB483.1 AFB484.1 AFB486.1 AFB487.1 AFB489.1 AFB493.1 AFB501.1 AFB503.1 AFB510.1 AFB514.1 AFB518.1 AFB520.1 AFB523.1 AFB526.1 AFB527.1 AFB530.1 AFB531.1 AFB533.1 AFB536.1 AFB538.1 AFB539.1 AFB540.1 AFB542.1 AFB543.1 AFB544.1 AFB545.1 AFB546.1 AFB547.1 AFB550.1 AFB551.1 AFB552.1 AFB553.1 AFB554.1 AFB555.1 AFB557.1 AFB558.1 AFB560.1 AFB562.1 AFB564.1 AFB565.1 AFB566.1 AFB567.1 AFB568.1 AFB569.1 AFB570.1 AFB571.1 AFB575.1 AFB576.1 AFB577.1 AFB578.1 AFB582.1 AFB583.1 AFB585.1 AFB586.1 AFB587.1 AFB588.1 AFB589.1 AFB590.1 AFB591.1 AFB592.1 AFB593.1 AFB594.1 AFB595.1 AFB596.1 AFB597.1 AFB598.1 AFB600.1 AFB603.1 AFB604.1 AFB605.1 AFB606.1 AFB607.1 AFB609.1 AFB610.1 AFB613.1 AFB615.1 AFB616.1 AFB617.1 AFB618.1 AFB619.1 AFB620.1 AFB621.1 AFB623.1 AFB625.1 AFB630.1 AFB632.1 AFB634.1 AFB636.1 AFB637.1 AFB638.1 AFB639.1 AFB640.1 AFB642.1 AFB644.1 AFB645.1 AFB646.1 AFB650.1 AFB652.1 AFB653.1 AFB654.1 AFB656.1 AFB660.1 AFB661.1 AFB662.1 AFB665.1 AFB666.1 AFB668.1 AFB678.1 AFB681.1 AFB683.1 AFB686.1 AFB688.1 AFB689.1 AFB690.1 AFB693.1 AFB694.1 AFB695.1 AFB696.1 AFB697.1 AFB698.1 AFB701.1 AFB704.1 AFB705.1 AFB706.1 AFB708.1 AFB711.1 AFB712.1 AFB713.1 AFB715.1 AFB719.1 AFB720.1 AFB721.1 AFB722.1 AFB724.1 AFB728.1 AFB729.1 AFB733.1 AFB734.1 AFB735.1 AFB736.1 AFB737.1 AFB738.1 AFB739.1 AFB741.1 AFB743.1 AFB744.1 AFB745.1 AFB747.1 AFB748.1 AFB749.1 AFB751.1 AFB752.1 AFB753.1 AFB754.1 AFB755.1 AFB756.1 AFB757.1 AFB759.1 AFB760.1 AFB761.1 AFB762.1 AFB763.1 AFB764.1 AFB765.1 AFB767.1 AFB768.1 AFB770.1 AFB771.1 AFB772.1 AFB774.1 AFB776.1 AFB777.1 AFB778.1 AFB779.1 AFB780.1 AFB783.1 AFB787.1 AFB790.1 AFB791.1 AFB792.1 AFB794.1 AFB795.1 AFB796.1 AFB798.1 AFB801.1 AFB802.1 AFB805.1 AFB806.1 AFB807.1 AFB808.1 AFB810.1 AFB811.1 AFB812.1 AFB813.1 AFB814.1 AFB815.1 AFB816.1 AFB818.1 AFB819.1 AFB825.1 AFB827.1 AFB829.1 AFB830.1 AFB832.1 AFB833.1 AFB834.1 AFB835.1 AFB837.1 AFB839.1 AFB842.1 AFB843.1 AFB844.1 AFB845.1 AFB846.1 AFB847.1 AFB849.1 AFB850.1 AFB852.1 AFB853.1 AFB858.1 AFB860.1 AFB862.1 AFB864.1 AFB866.1 AFB867.1 AFB871.1 AFB874.1 AFB875.1 AFB876.1 AFB877.1 AFB881.1 AFB882.1 AFB883.1 AFB884.1 AFB885.1 AFB887.1 AFB888.1 AFB889.1 AFB891.1 AFB893.1 AFB894.1 AFB899.1 AFB900.1 AFB902.1 AFB907.1 AFB910.1 AFB911.1 AFB914.1 AFB915.1 AFB916.1 AFB917.1 AFB921.1 AFB927.1 AFB928.1 AFB931.1 AFB932.1 AFB933.1 AFB935.1 AFB937.1 AFB938.1 AFB939.1 AFB941.1 AFB942.1 AFB943.1 AFB945.1 AFB950.1 AFB953.1 AFB954.1 AFB955.1 AFB962.1 AFB963.1 AFB964.1 AFB965.1 AFB970.1 AFB972.1 AFB973.1 AFB976.1 AFB977.1 AFB981.1 AFB983.1 AFB984.1 AFB987.1 AFB988.1 AFB992.1 AFB993.1 AFB994.1 AFB998.1 AFB999.1 AFC005.1 AFC007.1 AFG265.1 AFG266.1 AFG267.1 AFG269.1 AFG270.1 AFG271.1 AFG272.1 AFG277.1 AFG278.1 AFG279.1 AFG280.1 AFG281.1 AFG282.1 AFG284.1 AFG285.1 AFG286.1 AFG287.1 AFG289.1 AFG291.1 AFG292.1 AFG293.1 AFG297.1 AFG298.1 AFG299.1 AFG300.1 AFG301.1 AFG302.1 AFG304.1 AFG305.1 AFG309.1 AFG310.1 AFG312.1 AFG313.1 AFG314.1 AFG316.1 AFG317.1 AFG318.1 AFG321.1 AFG324.1 AFG327.1 AFG328.1 AFG329.1 AFG333.1 AFG334.1 AFG335.1 AFG336.1 AFG337.1 AFG338.1 AFG339.1 AFG340.1 AFG341.1 AFG342.1 AFG343.1 AFG345.1 AFG348.1 AFG351.1 AFG352.1 AFG353.1 AFG354.1 AFG357.1 AFG359.1 AFG360.1 AFG361.1 AFG364.1 AFG365.1 AFG366.1 AFG367.1 AFG368.1 AFG371.1 AFG372.1 AFG373.1 AFG375.1 AFG377.1 AFG378.1 AFG381.1 AFG382.1 AFG383.1 AFG385.1 AFG386.1 AFG395.1 AFG396.1 AFG398.1 AFG401.1 AFG402.1 AFG405.1 AFG406.1 AFG408.1 AFG409.1 AFG410.1 AFG416.1 AFG417.1 AFG421.1 AFG423.1 AFG427.1 AFG428.1 AFG430.1 AFG433.1 AFG434.1 AFG435.1 AFG438.1 AFG439.1 AFG441.1 AFG442.1 AFG444.1 AFG448.1 AFG449.1 AFG453.1 AFG455.1 AFG458.1 AFG459.1 AFG460.1 AFG461.1 AFG462.1 AFG463.1 AFG470.1 AFG478.1 AFG479.1 AFG480.1 AFG481.1 AFG483.1 AFG484.1 AFG486.1 AFG490.1 AFG491.1 AFG492.1 AFG493.1 AFG494.1 AFG497.1 AFG499.1 AFG500.1 AFG502.1 AFG506.1 AFG508.1 AFG510.1 AFG511.1 AFG512.1 AFG513.1 AFG514.1 AFG516.1 AFG517.1 AFG518.1 AFG519.1 AFG521.1 AFG522.1 AFG523.1 AFG524.1 AFG525.1 AFG526.1 AFG530.1 AFG531.1 AFG533.1 AFG537.1 AFG538.1 AFG540.1 AFG542.1 AFG543.1 AFG546.1 AFG548.1 AFG549.1 AFG550.1 AFG551.1 AFG552.1 AFG554.1 AFG555.1 AFG556.1 AFG557.1 AFG559.1 AFG562.1 AFG563.1 AFG566.1 AFG568.1 AFG570.1 AFG572.1 AFG573.1 AFG575.1 AFG579.1 AFG581.1 AFG583.1 AFG584.1 AFG585.1 AFG586.1 AFG588.1 AFG592.1 AFG593.1 AFG594.1 AFG597.1 AFG598.1 AFG599.1 AFG600.1 AFG602.1 AFG605.1 AFG608.1 AFG609.1 AFG610.1 AFG611.1 AFG612.1 AFG617.1 AFG618.1 AFG619.1 AFG623.1 AFG624.1 AFG625.1 AFG628.1 AFG629.1 AFG630.1 AFG632.1 AFG633.1 AFG635.1 AFG636.1 AFG638.1 AFG639.1 AFG641.1 AFG642.1 AFG647.1 AFG650.1 AFG651.1 AFG654.1 AFG657.1 AFG659.1 A

Quantity Affected: 41,745 devices (US-32,782, OUS-8,963)

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).

Type: Voluntary: Firm initiated

Recall Initiated: 2023-07-18

Company