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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Medical Device Identification Card

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  Class 2 Device Recall Medtronic Medical Device Identification Card see related information
Date Initiated by Firm September 15, 2015
Date Posted October 05, 2015
Recall Status1 Terminated 3 on April 14, 2016
Recall Number Z-0022-2016
Recall Event ID 72245
510(K)Number K932172  K883743  K940703  
Product Classification permanent pacemaker Electrode ID card - Product Code DTB
Product Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Code Information no codes on the cards
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact Medtronic Patient Services
800-551-5544
Manufacturer Reason
for Recall		 Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
FDA Determined
Cause 2		 Process control
Action On September 15, 2015, Medtronic began mailing an Important Medical Device Identification Card Notification letter, including a corrected Medical Device Identification Card, to impacted patients. The letter described the issue, provided a new corrected Identification Card, asked that the old card be destroyed immediately, and to begin using the new card. Patients can contact Medtronic Patient Services at 1-800-551-5544, option 1, followed by option 3, Monday - Friday, 8am - 5pm Central time.
Quantity in Commerce 777 cards
Distribution US nationwide distribution.
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.
510(K) Database 510(K)s with Product Code = DTB and Original Applicant = MEDTRONIC VASCULAR
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