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U.S. Department of Health and Human Services

Class 2 Device Recall Itrel 3 IPG; InterStim II INS: InterStim INS ; Enterra INS

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  Class 2 Device Recall Itrel 3 IPG; InterStim II INS: InterStim INS ; Enterra INS see related information
Date Initiated by Firm January 09, 2015
Date Posted June 26, 2015
Recall Status1 Terminated 3 on September 28, 2017
Recall Number Z-1147-2015
Recall Event ID 70271
PMA Number P840001 P970004 P970004 P080025 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead.

The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy. The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered.

The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric electrical stimulation (GES). The neurostimulator is a multiprogrammable device that accommodates a lead through which a stimulation program is delivered.
Code Information All lot/serial numbers are affected for all 4 Model numbers:  " Model 7425  " Model 3058  " Model 3023  " Model 3116  
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
Manufacturer Reason
for Recall		 Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.
FDA Determined
Cause 2		 Other
Action Consignees were sent a Medtronic {Medical Device Correction" letter dated January 9, 2015. The letter was addressed to Healthcare Professional. The letter described the issue and the product involved in the the recall. The letter also listed the Occurrence of the problem and labeling update. A Physician Reply Form was included which requested consignees to return the form to Medtronics. For questions they can contact Medtronic Neuromodulation Technical Services at 1-8007070944 weekdays 7 am 6 pm Central time. A second "Physician Notification Confirmation Form" was included to be completed by Medtronic Representatives.
Quantity in Commerce 396,975 (258,805 USA, 138,170 OUS)
Distribution Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada
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 = MEDTRONIC NEUROMODULATION
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