Terminated

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

FDA Recall Z-0278-2014 · Posted 2013-11-14

Recalling FirmMedtronic Neuromodulation

Recall StatusTerminated

Product CodeLGW

Date Initiated2013-09-30

Date Terminated2015-11-20

Product Quantity64,163

Reason for Recall

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).

Firm Action

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.

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.