Class 2 Device Recall Neuromodulation systems

• Date Initiated by Firm: September 12, 2017
• Create Date: October 17, 2017
• Recall Status: Terminated on April 16, 2020
• Recall Number: Z-0024-2018
• Recall Event ID: 78154
• PMA Number: P010032S096 P010032S134
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: Proclaim DRG Implantable Pulse Generator Model 3664
• Code Information: Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAP114.1 AAP267.1 AAP380.1 AAT623.1 ABM656.1 ABT952.1 ACD631.1 ACE905.1 ADJ588.1 ADJ614.1 ADJ842.1 ADJ852.1 ADJ855.1 ADJ863.1 ADJ872.1 ADJ910.1 ADK057.1 ADK078.1 ADK116.1 ADK186.1 ADK293.1 ADN214.1 ADN311.1 ADN340.1 ADN347.1 ADN376.1 ADN398.1 ADR256.1 ADR258.1 ADR260.1 ADR262.1 ADR289.1 ADR299.1 ADR302.1 ADR313.1 ADR362.1 ADR364.1 ADR365.1 ADR400.1 ADR401.1 ADR405.1 ADR410.1 ADR416.1 ADR421.1 ADR433.1 ADR434.1 ADR453.1 ADR457.1 ADR460.1 ADR461.1 ADR463.1 ADR464.1 ADR466.1 ADR469.1 ADR474.1 ADR475.1 ADR477.1 ADR485.1 ADR489.1 ADR492.1 ADR495.1 ADR497.1 ADR498.1 ADR501.1 ADR505.1 ADR509.1 ADR517.1 ADR519.1 ADR526.1 ADR543.1 ADR552.1 ADR557.1 ADR558.1 ADR563.1 ADR566.1 ADR575.1 ADR581.1 ADR598.1 ADR617.1 ADR630.1 ADR632.1 ADR655.1 ADR975.1 ADR986.1 ADS012.1 ADS039.1 ADW504.1 ADW624.1 ADW635.1 ADW686.1 ADW706.1 ADW707.1 ADW724.1 ADW930.1 AEH786.1 AEH900.1 AEJ018.1 AEJ059.1 AEM902.1 AFB279.1 AFB456.1 AFB710.1 AFB717.1 AFB934.1 AFG268.1 AFG397.1 AFG415.1 AFG464.1 AFG577.1 AFG587.1 AFG606.1 AFG780.1 AFG805.1 AFH511.1 AFH513.1 AFH514.1 AFH516.1 AFH518.1 AFH519.1 AFH521.1 AFH522.1 AFH524.1 AFH526.1 AFH527.1 AFH528.1 AFH530.1 AFH535.1 AFH538.1 AFH539.1 AFH543.1 AFH544.1 AFH545.1 AFH546.1 AFH547.1 AFH552.1 AFH554.1 AFH555.1 AFH556.1 AFH557.1 AFH558.1 AFH560.1 AFH561.1 AFH562.1 AFH563.1 AFH564.1 AFH565.1 AFH566.1 AFH570.1 AFH571.1 AFH572.1 AFH576.1 AFH579.1 AFH580.1 AFH582.1 AFH583.1 AFH584.1 AFH588.1 AFH589.1 AFH590.1 AFH592.1 AFH593.1 AFH594.1 AFH596.1 AFH597.1 AFH598.1 AFH599.1 AFH600.1 AFH601.1 AFH602.1 AFH605.1 AFH606.1 AFH607.1 AFH608.1 AFH609.1 AFH610.1 AFH614.1 AFH615.1 AFH618.1 AFH619.1 AFH620.1 AFH621.1 AFH624.1 AFH625.1 AFH626.1 AFH628.1 AFH629.1 AFH630.1 AFH631.1 AFH632.1 AFH633.1 AFH636.1 AFH641.1 AFH642.1 AFH646.1 AFH647.1 AFH648.1 AFH651.1 AFH654.1 AFH660.1 AFH663.1 AFH664.1 AFH665.1 AFH666.1 AFH668.1 AFH669.1 AFH671.1 AFH673.1 AFH674.1 AFH676.1 AFH684.1 AFH685.1 AFH687.1 AFH689.1 AFH695.1 AFH696.1 AFH697.1 AFH699.1 AFH700.1 AFH701.1 AFH702.1 AFH703.1 AFH706.1 AFH707.1 AFH708.1 AFZ281.1 AFZ365.1 AFZ581.1 AFZ582.1 AFZ592.1 AFZ620.1 AFZ631.1 AFZ637.1 AFZ642.1 AFZ649.1 AFZ661.1 AFZ685.1 AFZ691.1 AFZ695.1 AFZ710.1 AFZ711.1 AFZ728.1 AFZ730.1 AFZ768.1 AFZ780.1 AFZ870.1 AFZ881.1 AFZ893.1 AFZ908.1 AFZ915.1 AFZ918.1 AFZ930.1 AFZ933.1 AFZ970.1 AFZ972.1 AFZ978.1 AFZ979.1 AFZ981.1 AFZ998.1 AGA010.1 AGA012.1 AGA015.1 AGA029.1 AGA031.1 AGA032.1 AGA040.1 AGA044.1 AGA047.1 AGA049.1 AGA053.1 AGA061.1 AGA064.1 AGA067.1 AGA068.1 AGA071.1 AGA078.1 AGA083.1 AGA085.1 AGA087.1 AGA088.1 AGA094.1 AGA104.1 AGA108.1 AGA110.1 AGA113.1 AGM588.1 AGM603.1 AGN178.1 AGN273.1 AGN393.1 AGN394.1 AGN429.1 AGN476.1 AGN514.1 AGU357.1 AHD592.1 AHD733.1 AHD737.1 AHD739.1 AHD742.1 AHD745.1 AHD756.1 AHD759.1 AHD760.1 AHD763.1 AHD766.1 AHD775.1 AHD787.1 AHD795.1 AHD800.1 AHK478.1 AHK479.1 AHK480.1 AHK483.1 AHK485.1 AHK489.1 AHK491.1 AHK493.1 AHK498.1 AHK507.1 AHK516.1 AHK520.1 AHK527.1 AHK529.1 AHK533.1 AHK538.1 AHK540.1 AHK549.1 AHK570.1 AHK574.1 AHK583.1 AHK591.1 AHK601.1 AHK605.1 AHK610.1 AHK615.1 AHK655.1 AHK656.1 AHK688.1 AHK689.1 AHK722.1 AHK733.1 AHK736.1 AHK743.1 AHK763.1 AHK774.1 AHK812.1 AHK826.1 AHK959.1 AHL025.1 AHL058.1 AHL172.1 AHL182.1 AHV709.1 AHV710.1 AHV714.1 AHV715.1 AHV720.1 AHV732.1 AHV742.1 AHV752.1 AHV754.1 AHV757.1 AHV759.1 AHV761.1 AHV765.1 AHV766.1 AHV770.1 AHV777.1 AHV781.1 AHV995.1 AHW119.1 AHW177.1 AHW181.1 AHW187.1 AHW189.1 AHW191.1 AHW205.1 AHW206.1 AHW211.1 AHW213.1 AHW214.1 AHW230.1 AHW232.1 AHW240.1 AHW243.1 AHW251.1 AHW257.1 AHW261.1 AHW265.1 AHW277.1 AHW284.1 AHW310.1 AHW317.1 AHW329.1 AHW337.1 AHW341.1 AHW344.1 AHW345.1 AHW353.1 AHW358.1 AHW373.1 AHW377.1 AHW386.1 AHW389.1 AHW399.1 AHW400.1 AHW411.1 AHW419.1 AHW422.1 AHW423.1 AHW427.1 AHW439.1 AHW444.1 AHW448.1 AHW455.1 AHW458.1 AHW459.1 AHW460.1 AHW468.1 AHW469.1 AHW473.1 AHW478.1 AHW486.1 AHW509.1 AHW511.1 AHW516.1 AHW518.1 AHW520.1 AHW521.1 AHW524.1 AHW530.1 AHW536.1 AHW538.1 AHW539.1 AHW540.1 AHW549.1 AHW560.1 AHW566.1 AHW576.1 AHW597.1 AHW601.1 AHW617.1 AHW620.1 AHW622.1 AHW624.1 AHW634.1 AHW639.1 AHW644.1 AHW645.1 AHW649.1 AHW652.1 AJR080.1 AJW366.1 AJW459.1 AJW507.1 AJW511.1 AJW554.1 AJW558.1 AJW572.1 AJW580.1 AJW596.1 AJW607.1 AJW621.1 AJW623.1 AKB521.1 AKB527.1 AKB531.1 AKB537.1 AKB560.1 AKB565.1 AKB566.1 AKB573.1 AKB584.1 AKB595.1 AKB598.1 AKB612.1 AKB613.1 AKB614.1 AKB621.1 AKB633.1 AKB638.1 AKB640.1 AKB642.1 AKB650.1 AKB654.1 AKB675.1 AKB682.1 AKB683.1 AKB712.1 AKB714.1 AKB719.1 AKB724.1 AKB734.1 AKB736.1 AKB755.1 AKB756.1 AKB759.1 AKB762.1 AKB767.1 AKB776.1 AKB779.1 AKB780.1 AKB783.1 AKB785.1 AKB802.1 AKB806.1 AKB809.1 AKB810.1 AKB814.1 AKB825.1 AKB828.1 AKB832.1 AKB843.1 AKB848.1 AKB856.1 AKB864.1 AKB866.1 AKB869.1 AKB876.1 AKB881.1 AKB896.1 AKB897.1 AKB901.1 AKB903.1 AKB922.1 AKB940.1 AKB942.1 AKB951.1 AKB952.1 AKB956.1 AKB959.1 AKB962.1 AKB974.1 AKB979.1 AKB981.1 AKB985.1 AKB994.1 AKC002.1 AKC007.1 AKC010.1 AKC012.1 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APC071.1 APC075.1 APC110.1 APE452.1 APE492.1 APE504.1 APE516.1 APE517.1 APE522.1 APE538.1 APE547.1 APE550.1 APE551.1 APE567.1 APE569.1 APE575.1 APE577.1 APE583.1 APE584.1 APE590.1 APE591.1 APE630.1 APE640.1 APE642.1 APE650.1 APE663.1 APE693.1 APE708.1 APE709.1 APE714.1 APE727.1 APE734.1 APE740.1 APE742.1 APE745.1 APE762.1 APE792.1 APE805.1 APE813.1 APE894.1 APE899.1 APE923.1 APE953.1 APE960.1 APE961.1 APE983.1 APE990.1 APE991.1 APF002.1 APF005.1 APF006.1 APF007.1 APF011.1 APF029.1 APF033.1 APF114.1 APF160.1 APF192.1 APK895.1 APK900.1 APK901.1 APK924.1 APK928.1 APK955.1 APK956.1 APK963.1 APK974.1 APK978.1 APK979.1 APK990.1 APK993.1 APK996.1 APL039.1 APL045.1 APL059.1 APL072.1 APL086.1 APL100.1 APL103.1 APL114.1 APL146.1 APL154.1 APL159.1 APL177.1 APL194.1 APL210.1 APL211.1 APL216.1 APL217.1 APL248.1 APL250.1 APL254.1 APL261.1 APL262.1 APL269.1 APL275.1 APL276.1 APL279.1 APL291.1 APL293.1 APL303.1 APL305.1 APL306.1 APL307.1 APL327.1 APL330.1 APL334.1 APL344.1 APL348.1 APL349.1 APL350.1 APL361.1 APL362.1 APL363.1 APL364.1 APL367.1 APL373.1 APL383.1 APL384.1 APL389.1 APL401.1 APL420.1 APL423.1 APL426.1 APL428.1 APL431.1 APL444.1 APL450.1 APL451.1 APL452.1 APL453.1 APL462.1 APL486.1 APL491.1 APL492.1 APL496.1 APL529.1 APL547.1 APL549.1 APL565.1 APL576.1 APL590.1 APL592.1 APL601.1 APL602.1 APL613.1 APL621.1 APL622.1 APL630.1 APL637.1 APS036.1 APS039.1 APS053.1 APS067.1 APS068.1 APS070.1 APS071.1 APS084.1 APS095.1 APS104.1 APS119.1 APS125.1 APS126.1 APS140.1 APS148.1 APS151.1 APS153.1 APS154.1 APS155.1 APS202.1 APS236.1 APS237.1 APS238.1 APS262.1 APS266.1 APS278.1 APS281.1 APS285.1 APS314.1 APS325.1 APS326.1 APS327.1 APS345.1 APS347.1 APS351.1 APS357.1 APS361.1 APS363.1 APS365.1 APS373.1 APS375.1 APS400.1 APS424.1 APS436.1 APS447.1 APS448.1 APS457.1 APS469.1 APS501.1 APS514.1 APZ186.1 APZ192.1 APZ238.1 APZ251.1 APZ256.1 APZ276.1 APZ277.1 APZ300.1 APZ301.1 APZ323.1 APZ330.1 APZ350.1 APZ412.1 APZ456.1 APZ459.1 APZ560.1 APZ561.1 APZ564.1 APZ587.1 APZ594.1 APZ598.1 APZ608.1 APZ613.1 APZ614.1 APZ618.1 APZ638.1 APZ667.1 APZ670.1 APZ682.1 APZ697.1 APZ710.1 APZ721.1 APZ722.1 APZ758.1 APZ761.1 APZ776.1 APZ819.1 APZ826.1 APZ828.1 ARF828.1 ARF833.1 ARF858.1 ARF859.1 ARF860.1 ARF862.1 ARF867.1 ARF877.1 ARF880.1 ARF885.1 ARF889.1 ARF897.1 ARF949.1 ARF950.1 ARF953.1 ARF961.1 ARF964.1 ARF966.1 ARF970.1 ARF971.1 ARF976.1 ARF982.1 ARF993.1 ARG024.1 ARG028.1 ARG033.1 ARG037.1 ARG039.1 ARG044.1 ARG045.1 ARG047.1 ARG050.1 ARG056.1 ARG059.1 ARG068.1 ARG077.1 ARG123.1 ARG133.1 ARG140.1 ARG146.1 ARG156.1 ARG166.1 ARG168.1 ARG180.1 ARG186.1 ARG196.1 ARG201.1 ARG211.1 ARG214.1 ARG216.1 ARG222.1 ARG226.1 ARG227.1 ARG239.1 ARG254.1 ARG260.1 ARG264.1 ARG265.1 ARG266.1 ARG271.1 ARG273.1 ARG274.1 ARG276.1 ARG280.1 ARG282.1 ARG285.1 ARG297.1 ARG317.1 ARG321.1 ARG340.1 ARG344.1 ARG350.1 ARG368.1 ARG369.1 ARG373.1 ARG379.1 ARG382.1 ARG438.1 ARG442.1 ARG446.1 ARG447.1 ARG462.1 ARG477.1 ARG488.1 ARG490.1 ARG496.1 ARG501.1 ARG502.1 ARG503.1 ARG510.1 ARG512.1 ARG521.1 ARG522.1 ARG525.1 ARG526.1 ARG529.1 ARG535.1 ARG541.1 ARG542.1 ARG550.1 ARG634.1 ARG635.1 ARG639.1 ARG643.1 ARG645.1 ARG649.1 ARG650.1 ARG661.1 ARG662.1 ARJ277.1 ARK058.1 ARK064.1 ARK065.1 ARK092.1 ARK111.1 ARK144.1 ARK149.1 ARK166.1 ARK172.1 ARK188.1 ARK206.1 ARK218.1 ARK219.1 ARK222.1 ARK223.1 ARK224.1 ARK228.1 ARK242.1 ARK244.1 ARK247.1 ARK258.1 ARK261.1 ARK267.1 ARK277.1 ARK288.1 ARK301.1 ARK325.1 ARK335.1 ARK337.1 ARK347.1 ARK356.1 ARK367.1 ARK403.1 ARK404.1 ARK409.1 ARK411.1 ARK414.1 ARK416.1 ARK417.1 ARK435.1 ASJ075.1 ASM524.1 ASM531.1 ASM665.1 ASM687.1 ASM692.1 ASM765.1 ASR938.1 ASV349.1 ASV352.1 ASV357.1 ASV360.1 ASV370.1 ASV374.1 ASV412.1 ASV433.1 ASV462.1 ASV463.1 ASV603.1 ASV691.1 ASV693.1 ASV739.1 ASV746.1 ASV761.1 ASV844.1 ASV854.1 ASV875.1 ASV895.1 ASV942.1 ASV957.1 ASV959.1 ASW057.1 ASW084.1 YW0086.1 ZS0578.1 ZX5726.1 ZX5848.1
• Recalling Firm/ Manufacturer: St. Jude Medical, Inc.; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: Justin Paquette; 651-756-6293
• Manufacturer Reason for Recall: Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
• FDA Determined Cause: Software design
• Action: St. Jude Medical sent an Important Medical Device Advisory letter dated September 12, 2017, to all affected customers. Customers were advised the following: Phase I: ERI Assessment ¿ If a patient reports that an ERI message is displayed on the PC, please contact your Abbott Representative to obtain the device-specific generator logs and to conduct the ERI Assessment using the steps in Appendix B prior to making an elective replacement decision. ¿ After the ERI Assessment is completed, follow-up communication from your Abbott representative will be provided in order to make appropriate decisions. The response will be one of two possible responses: o ERI is valid at this time for this device, follow existing information provided by IFU and CP for the elective replacement window for this device. o The device has the appropriate level of battery voltage to provide the existing therapy until the next assessment, which should occur no later than March 2018. During this period, the ERI message will be displayed on the PC at the start of each session. This message may be dismissed to enter the session on the PC. Phase II: ERI Software Update Abbott will deploy a software upgrade, upon approval by local governing agencies that addresses the errors in calculation causing the inappropriate ERI message. When this software update is deployed, the Phase I ERI assessment process is no longer needed. After the CP is updated, replacement decisions can be made following the revised instructions for use, which will be available at manuals.sjm.com. Once approved for use in your area, notification of the availability of this software update will occur through the Apple¿ Public App Store for the PC and through the SJM App Catalog for the CP. Should you have questions about patient management, including questions regarding error messages related to IPGs, please contact your local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S) and +46 8 474 414
• Quantity in Commerce: 1744 devices
• Distribution: Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LGW and Original Applicant = Abbott Medical