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Proclaim DRG Implantable Pulse Generator Model 3664

FDA Device Recall #Z-0024-2018 — Class II — September 12, 2017

Recall Summary

Recall Number Z-0024-2018
Classification Class II — Moderate risk
Date Initiated September 12, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm St. Jude Medical, Inc.
Location Plano, TX
Product Type Devices
Quantity 1744 devices

Product Description

Proclaim DRG Implantable Pulse Generator Model 3664

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.

Distribution Pattern

Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)

Lot / 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 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APB219.1 APB224.1 APB232.1 APB240.1 APB242.1 APB260.1 APB276.1 APB297.1 APB304.1 APB321.1 APB323.1 APB324.1 APB334.1 APB335.1 APB344.1 APB350.1 APB355.1 APB359.1 APB364.1 APB375.1 APB383.1 APB388.1 APB390.1 APB392.1 APB398.1 APB403.1 APB412.1 APB415.1 APB441.1 APB446.1 APB476.1 APB478.1 APB482.1 APB499.1 APB525.1 APB528.1 APB532.1 APB541.1 APB546.1 APB547.1 APB555.1 APB556.1 APB565.1 APB595.1 APB603.1 APB607.1 APB608.1 APB618.1 APB619.1 APB620.1 APB634.1 APB640.1 APB642.1 APB658.1 APB677.1 APB678.1 APB685.1 APB694.1 APB695.1 APB708.1 APB709.1 APB713.1 APB723.1 APB726.1 APB751.1 APB753.1 APB764.1 APB765.1 APB766.1 APB768.1 APB780.1 APB801.1 APB802.1 APB805.1 APB827.1 APB836.1 APB840.1 APB844.1 APB852.1 APB862.1 APB870.1 APB873.1 APB877.1 APB893.1 APB894.1 APB902.1 APB911.1 APB916.1 APB928.1 APB929.1 APB930.1 APB931.1 APB934.1 APB938.1 APB939.1 APB941.1 APB970.1 APB983.1 APC015.1 APC017.1 APC028.1 APC032.1 APC037.1 APC041.1 APC058.1 APC060.1 APC061.1 APC068.1 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

Other Recalls from St. Jude Medical, Inc.

Recall # Classification Product Date
Z-0593-2019 Class II St. Jude Medical InfinityTM DBS System 8CH Dire... Oct 11, 2018
Z-1170-2018 Class II Proclaim DRG Implantable Pulse Generator, Model... Mar 9, 2018
Z-0022-2018 Class II Proclaim 5 Elite Implantable Pulse Generator an... Sep 12, 2017
Z-0023-2018 Class II Infinity 5 Implantable Pulse Generator and Infi... Sep 12, 2017
Z-2693-2017 Class II Infinity 5, Implantable Pulse Generator, REF 66... Jun 2, 2017

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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