Class 3 Device Recall Medtronic Lead Kit

• Date Initiated by Firm: August 02, 2006
• Date Posted: September 29, 2006
• Recall Status: Terminated on December 31, 2006
• Recall Number: Z-1537-06
• Recall Event ID: 36164
• Product Classification: Spinal cord Stimulation lead - Product Code LGW
• Product: Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
• Code Information: Model 3778, Lot V009546
• Recalling Firm/ Manufacturer: Medtronic Neurological; 800 53rd Ave NE; PO Box 1250; Minneapolis MN 55440-1250
• Manufacturer Reason for Recall: Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.
• FDA Determined Cause: Other
• Action: Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information.
• Quantity in Commerce: 22 total
• Distribution: Nationwide distribution --- including states of CA, GA, KY, LA, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.