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Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The I...

FDA Device Recall #Z-2693-2017 — Class II — June 2, 2017

Recall Summary

Recall Number Z-2693-2017
Classification Class II — Moderate risk
Date Initiated June 2, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm St. Jude Medical, Inc.
Location Plano, TX
Product Type Devices
Quantity 443 units

Product Description

Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.

Reason for Recall

The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

AAD255.1 AAN997.1 AAP279.1 AAP328.1 AAP333.1 AAT509.1 AAT579.1 AAT582.1 AAT652.1 AAT783.1 AAT792.1 AAT795.1 AAT797.1 AAT804.1 AAT845.1 AAT902.1 AAT976.1 AAT987.1 AAT989.1 AAU003.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABA946.1 ABM329.1 ABM630.1 ABT798.1 ABT841.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE900.1 ACE936.1 ACE939.1 ACE994.1 ACF065.1 ACK145.1 ACK161.1 ACK241.1 ACK424.1 ACK511.1 ACK514.1 ACK549.1 ACK559.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP680.1 ACP686.1 ACP687.1 ACP700.1 ACP770.1 ACP780.1 ACP824.1 ACP833.1 ACP835.1 ACP869.1 ACP872.1 ACP874.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACU349.1 ACU373.1 ACU381.1 ACU424.1 ADR679.1 ADR787.1 ADR794.1 ADR852.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH733.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 AEH883.1 AEH951.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 AEJ100.1 AEJ101.1 AEJ106.1 AEJ111.1 AEJ145.1 AEJ148.1 AEJ164.1 AEJ167.1 AEJ203.1 AEJ241.1 AEJ251.1 AEJ252.1 AEJ257.1 AEM803.1 AEM833.1 AEM852.1 AEM857.1 AEM877.1 AEM885.1 AEM887.1 AEM888.1 AEM917.1 AEM951.1 AEM964.1 AEM967.1 AEM969.1 AEM988.1 AFB225.1 AFB349.1 AFB376.1 AFB425.1 AFB433.1 AFB434.1 AFB436.1 AFB444.1 AFB454.1 AFB495.1 AFB658.1 AFG344.1 AFG446.1 AFG471.1 AFG496.1 AFG545.1 AFG668.1 AFG672.1 AFG679.1 AFG704.1 AFG724.1 AFG947.1 AFG959.1 AFZ174.1 AFZ211.1 AFZ224.1 AFZ260.1 AFZ359.1 AFZ364.1 AFZ384.1 AFZ409.1 AFZ427.1 AFZ532.1 AFZ588.1 AFZ590.1 AFZ807.1 AFZ835.1 AFZ851.1 AFZ996.1 AGM602.1 AGM732.1 AGM765.1 AGM950.1 AGN231.1 AGN324.1 AGN447.1 AGN490.1 AGN552.1 AGN616.1 AHD572.1 AHD578.1 AHD589.1 AHD612.1 AHD646.1 AHD648.1 AHD663.1 AHD677.1 AHD686.1 AHD713.1 AHD818.1 AHD821.1 AHD822.1 AHK567.1 AHK727.1 AHK778.1 AHK897.1 AHK906.1 AHK922.1 AHK976.1 AHL049.1 AHL054.1 AHL069.1 AHL093.1 AHL095.1 AHL097.1 AHL105.1 AHL122.1 AHL133.1 AHL135.1 AHL138.1 AHL195.1 AHV557.1 AHV591.1 AHV603.1 AHV679.1 AHV705.1 AHV797.1 AHV801.1 AHV802.1 AHV807.1 AHV810.1 AHV818.1 AHV824.1 AHV843.1 AHV851.1 AHV854.1 AHV855.1 AHV860.1 AHV873.1 AHV921.1 AHV937.1 AHV945.1 AHV947.1 AHV965.1 AHV971.1 AHV975.1 AHV992.1 AHW028.1 AHW049.1 AHW055.1 AHW080.1 AHW082.1 AHW085.1 AHW104.1 AHW156.1 AHW489.1 AHW492.1 AHW496.1 AHW498.1 AHW661.1 AHW663.1 AHW670.1 AHW683.1 AJP994.1 AJP995.1 AJR053.1 AJR058.1 AJR073.1 AJR075.1 AJR076.1 AJR077.1 AJW280.1 AJW285.1 AJW287.1 AJW290.1 AJW296.1 AJW310.1 AJW328.1 AJW329.1 AJW334.1 AJW336.1 AJW345.1 AJW365.1 AJW382.1 AJW384.1 AJW388.1 AJW393.1 AJW412.1 AJW422.1 AJW431.1 AJW461.1 AJW487.1 AKX628.1 ALE668.1 ALE944.1 ALJ257.1 ALJ402.1 ALJ928.1 ALJ984.1 ALJ992.1 ALN367.1 ALN378.1 ALN429.1 ALN438.1 ALN441.1 ALN444.1 ALN448.1 ALN451.1 ALN469.1 ALN477.1 ALN487.1 ALN547.1 ALN593.1 ALN596.1 ALN622.1 ALN628.1 ALN634.1 ALN658.1 ALX037.1 ALX043.1 ALX053.1 ALX085.1 ALX203.1 ALX313.1 ALY252.1 ALY270.1 ALY272.1 ALY313.1 ALY329.1 ALY367.1 ALY369.1 ALY371.1 ALY400.1 ALY431.1 ALY533.1 ALY544.1 ALY610.1 ALY624.1 ALY625.1 ALY636.1 ALY653.1 ALY660.1 ALY774.1 ALY778.1 ALY799.1 ALY801.1 ALY802.1 ALY810.1 ALZ039.1 ALZ051.1 ALZ064.1 ALZ080.1 ALZ311.1 AMK053.1 AMN786.1 AMN963.1 AMP153.1 AMP226.1 AMS002.1 AMS004.1 AMS007.1 AMS022.1 AMS024.1 AMS026.1 AMS038.1 AMS068.1 AMS073.1 AMS126.1 AMS127.1 AMS161.1 AMS169.1 AMS193.1 AMS228.1 AMS241.1 AMS248.1 AMS256.1 AMS258.1 AMS259.1 AMS270.1 AMS271.1 AMS400.1 AMS431.1 AMS879.1 AMT051.1 AMT260.1 AMT351.1 ANG969.1 ANG990.1 ANH036.1 ANH126.1 ANH170.1 ANH185.1 ANH258.1 ANH278.1 ANH468.1 ANH503.1 ANH603.1 ANH618.1 ANH636.1 ANL856.1 YY2921.1 YY5780.1 YY5876.1 YY6049.1 YY6118.1 YZ1385.1 YZ1487.1 YZ1509.1 YZ1511.1 YZ1514.1 YZ1515.1 YZ1531.1 YZ1574.1 YZ1595.1 YZ9624.1 YZ9636.1 YZ9648.1 YZ9651.1 YZ9654.1 YZ9683.1 YZ9691.1 YZ9702.1 YZ9709.1 YZ9712.1 YZ9713.1 YZ9724.1 YZ9732.1 YZ9749.1 YZ9755.1 YZ9768.1 YZ9826.1 YZ9857.1 ZK3232.1 ZK3240.1 ZK3253.1 ZK3370.1 ZV3919.1 ZW0254.1 ZW0302.1 ZW0587.1 ZW8865.1 ZW8885.1 ZW8943.1 ZW8991.1 ZY8811.1 ZY8821.1 ZY9321.1 ZY9369.1 ZY9406.1

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Z-0022-2018 Class II Proclaim 5 Elite Implantable Pulse Generator an... Sep 12, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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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