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The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a… recallZ-1147-2015 · Medtronic Neuromodulation · initiated Jan 9, 2015

Class II Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1147-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 9, 2015
Posted by the FDA
Jun 26, 2015
Recalling firm
Medtronic Neuromodulation
Quantity
396,975 (258,805 USA, 138,170 OUS)
Product code
LGW
FDA submissions
P840001, P970004, P970004, P080025
Distribution
Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada

Product description

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 (models, lots, serial numbers)

All lot/serial numbers are affected for all 4 Model numbers:  " Model 7425  " Model 3058  " Model 3023  " Model 3116

Other devices under the same FDA submission

176 devices cleared under P840001, P970004, P970004, P080025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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