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Medtronic implantable pulse generator: ATTESTA L DR MRI… recallZ-0807-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Jan 17, 2019

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-0807-2019
Status
Open, Classified
Initiated by the company
Jan 17, 2019
Posted by the FDA
Feb 14, 2019
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity
9915 units
Product code
NVZ
FDA submissions
P980035
Distribution
Wordlwide

Product description

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 (models, lots, serial numbers)

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

Other devices under the same FDA submission

71 devices cleared under P980035 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 81945).

Sources and updates

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