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U.S. Department of Health and Human Services

Class 2 Device Recall Proclaim DRG Implantable Pulse Generator

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  Class 2 Device Recall Proclaim DRG Implantable Pulse Generator see related information
Date Initiated by Firm March 09, 2018
Date Posted March 23, 2018
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-1170-2018
Recall Event ID 79560
PMA Number P150004S002 
Product Classification Implantable pulse generator, programmer and battery charger - Product Code PMP
Product Proclaim DRG Implantable Pulse Generator, Model Number 3664
Code Information Lot Number 6210849 Serial Number AVM174.1  Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1  Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1  Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1,  AVK678.1, AVN837.1   Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1  Lot Number 6278155 Serial Number AVK896.1    
Recalling Firm/
Manufacturer		 St. Jude Medical, Inc.
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact Justin Paquette
651-756-6293
Manufacturer Reason
for Recall		 The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
FDA Determined
Cause 2		 Software change control
Action Notification material in the form of a Customer Letter was hand-delivered to two consignees in the US beginning 09 Mar 2018. The Physician Letter was hand-delivered to impacted implanting physicians, beginning 14 Mar 2018. A Patient Letter was delivered via certified mailing to all active implanted patients in the US, beginning 14 Mar 2018.
Quantity in Commerce 17 units
Distribution US
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 = PMP and Original Applicant = Abbott Medical
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