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U.S. Department of Health and Human Services

Class 1 Device Recall SENSIA, Dual chamber pacemaker

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  Class 1 Device Recall SENSIA, Dual chamber pacemaker see related information
Date Initiated by Firm January 17, 2019
Date Posted February 14, 2019
Recall Status1 Open3, Classified
Recall Number Z-0809-2019
Recall Event ID 81945
PMA Number P980035 
Product Classification Pulse generator, permanent, implantable - Product Code NVZ
Product Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):
(a) Model Number SED01
(b) Model Number SEDR01
(c) Model Number SEDRL1
Code Information SENSIA, Dual chamber pacemaker (DDD):  (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers 
Recalling Firm/
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
Manufacturer Reason
for Recall
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
FDA Determined
Cause 2
Component design/selection
Action In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand deliver an FCA Notification Letter to consignees including implanting and follow-up physicians. In consultation with an Independent Physician Quality Panel (IPQP), patient management recommendations were provided with the FCA Notification letter to ensure patient safety. Medtronic Field Representatives will hand deliver an additional Supplemental Letter with the Urgent Medical Device Recall letter to a subset of physicians with patients whose device has shown evidence of a pacing pause that is potentially related to this circuit error. Consignees will be asked to return all unused and unopened affected product to Medtronic.
Quantity in Commerce 59232 units
Distribution Wordlwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NVZ and Original Applicant = MEDTRONIC Inc.