| Class 1 Device Recall ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker |  |
Date Initiated by Firm | January 17, 2019 |
Date Posted | February 14, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0807-2019 |
Recall Event ID |
81945 |
PMA Number | P980035 |
Product Classification |
Pulse generator, permanent, implantable - Product Code NVZ
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Product | Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):
(a) Model Number ATDR01
(b) Model Number ATDRL1
(c) Model Number ATDRS1 |
Code Information |
ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01, GTIN: 00643169882911, 00763000109059, All Serial Numbers (b) Model Number ATDRL1, GTIN: 00643169882928, 00763000109066, All Serial Numbers (c) Model Number ATDRS1, GTIN: 00643169882935, 00763000109073, All Serial Numbers |
Recalling Firm/ Manufacturer |
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 8200 Coral Sea St Ne Mounds View MN 55112-4391
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For Additional Information Contact | Technical Services 800-505-4636 |
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 | 9915 units |
Distribution | Wordlwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = NVZ
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