—#132742

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.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001, P970004, P970004, P080025
Affected lot / code info: All lot/serial numbers are affected for all 4 Model numbers: " Model 7425 " Model 3058 " Model 3023 " Model 3116

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada

Timeline

Recall initiated: 2015-01-09
Posted by FDA: 2015-06-26
Terminated: 2017-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132742. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.