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U.S. Department of Health and Human Services

Class 2 Device Recall RestoreUltra and RestoreSensor

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 Class 2 Recall
RestoreUltra and RestoreSensor
see related information
Date Posted November 14, 2013
Recall Status1 Open
Recall Number Z-0278-2014
Recall Event ID 66506
Premarket Approval
PMA Number
P840001
Product Classification Stimulator, Spinal-Cord, Totally Implanted For Pain Relief - Product Code LGW
Product Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Code Information all serial numbers
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
For Additional Information Contact Technical Services
800-707-0933
Manufacturer 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).
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 64,163
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LGW and Applicant = MEDTRONIC INC.
PMAs with Product Code = LGW and Applicant = MEDTRONIC NEUROLOGICAL
PMAs with Product Code = LGW and Applicant = MEDTRONIC NEUROMODULATION
PMAs with Product Code = LGW and Applicant = MEDTRONIC VASCULAR
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