Z-0024-2018Class II

Proclaim DRG Implantable Pulse Generator Model 3664

Name: Z-0024-2018 Proclaim DRG Implantable Pulse Generator Model 3664
Creator: St. Jude Medical, Inc.
Published: 2017-09-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-09-12 / Terminated / root cause: software

FDA source

St. Jude Medical, Inc. began a recall of Proclaim DRG Implantable Pulse Generator Model 3664 on 2017-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0024-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Posted: 2017-10-17
Terminated: 2020-04-16
Recalling firm: Abbott Medical
Product: Proclaim DRG Implantable Pulse Generator Model 3664
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: software
FDA root 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)
Product codes and lots: 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 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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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0024-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0022-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-17
Z-0023-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-17
Z-0024-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-17

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)