Recall Z-0582-2018 · NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

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

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable devices that automatically detect and treat episodes of ventricular fibr

Date	Feb 1, 2018 (initiated Dec 19, 2017)
Status	Terminated
Reason	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Root cause	Process design
Action	On 12/19/2017, Medtronic verbally notified consignees and retrieved eight devices at sites that had affected inventory on hand. On 01/22/2018, Medtronic provided a recall notification letter to physicians following 48 patients implanted with affected devices and risk managers of those medical facilities, recommending that physicians strongly consider prophylactic device replacement for patients implanted with an affected device. Medtronic Technical Services is available to assist physicians with questions at 800-723-4636. Medtronic Patient Service is available to assist patients at 800-551-55
Quantity	951 devices total
Distribution	US Nationwide Distribution.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.