—#122513

Product

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.

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: all serial numbers

Why it was recalled

Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

Root cause (FDA determination)

Software design

Action the firm took

In September 2013 Medtronic issued a medical device correction letter titled "Loss of Stimulation and Over Stimulation" to customers associated with the affected Medtronic neurostimulators. This letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues. Medtronic field representatives will be updating the model 8870 software application card to version AAR/01, which is contained in the physician programmer. A Physician Reply Form was asked to be signed and returned by fax or mail for acknowledging the receipt of the Urgent Medical Device Correction letter. When the Medtronic field rep updates the software application card of the physicains' programmer, they will complete a Rep Reply For: 8870 Card Update to AAR/01.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.

Timeline

Recall initiated: 2013-09-30
Posted by FDA: 2013-11-14
Terminated: 2015-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.