Class 2 Device Recall Rapid Programmer

• Date Initiated by Firm: June 02, 2009
• Date Posted: August 30, 2011
• Recall Status: Terminated on September 27, 2012
• Recall Number: Z-3091-2011
• Recall Event ID: 57806
• PMA Number: P010032
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.
• Code Information: Serial numbers: 101565, 101544, 101555, 101548, 101561, 101551, 101563, 101546, 101556, 101553, 101554, 101558, 101545, and 101566
• Recalling Firm/ Manufacturer: Advanced Neuromodulation Systems; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: 972-309-2154
• Manufacturer Reason for Recall: Product programmed with unapproved software was distributed.
• FDA Determined Cause: Software change control
• Action: St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken. All affected devices were returned to the firm as instructed.
• Quantity in Commerce: 14 units
• Distribution: Distributed in New Hampshire and Puerto Rico.
• 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.

• PMA Database: PMAs with Product Code = LGW