Recall Z-0810-2019 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
| Date | Feb 14, 2019 (initiated Jan 17, 2019) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 c |
| Quantity | 5392 units |
| Distribution | Wordlwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.