Recall Z-2413-2018 ยท NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart
| Date | Jul 10, 2018 (initiated Jun 21, 2018) |
| Status | Terminated |
| Reason | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP). |
| Root cause | Device Design |
| Action | On 21-Jun-2018, Medtronic began notifying US physicians and health care professionals of this issue and provided Patient Management recommendations to ensure patient safety. A Software Update to SW040 Version 8.1 will be deployed to all Medtronic 2090 and Encore clinic and hospital programmers via the Software Distribution Network or USB. Field Representatives with customers who have Percepta CRT-P patients will be sent a USB device loaded with the updated software. In consultation with an Independent Physician Quality Panel, Medtronic recommends the following actions for physicians fol |
| Quantity | 6712 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.