—#123720

Product

Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001
Affected lot / code info: The first released affected product was released to the market in April, 2005.

Why it was recalled

Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Medtronic sent a Medical Device Correction letter dated February 2014 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: If you have patients with cycling enabled or wish to use cycling, use the updated calculations and graphs available online at professional.medtronic.com/cycling to assess the impact of cycling on device longevity. Medtronic will update the product labeling in the second half of 2014. " Remind your patients to continue to check their battery status. Instructions on how to check battery status can be found in the patient programmer or recharger system manual. " Pain Stimulation Trialing Only: The cycling feature should not be enabled on the External Neurostimulator (ENS) when estimating device longevity because the resulting longevity estimate for non-rechargeable devices may not provide accurate information. Consignees were also instructed to acknowledge receipt of the notice by completing the attached reply form and returning it to Medtronic using the contact details on the reply form. For questions consignees can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekdays 7am - 6pm CST. For questions regarding this recall call 800-707-0933.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution - all states including DC and Puerto Rico.

Timeline

Recall initiated: 2014-02-27
Posted by FDA: 2014-04-29
Terminated: 2014-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123720. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.