Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model

FDA device recall Z-0810-2019 · posted 2019-02-14 · Open, Classified

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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

Action taken

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.

Root cause

Component design/selection

Status

Open, Classified

Product code

NVZ

Quantity affected

5392 units

Distribution

Wordlwide

Date initiated

2019-01-17

Date posted

2019-02-14

Location

Mounds View, MN