Class 1 Device Recall Compia MRI CRTD, Compia MRI Quad CRTD,

• Date Initiated by Firm: December 19, 2017
• Date Posted: February 01, 2018
• Recall Status: Terminated on August 27, 2021
• Recall Number: Z-0583-2018
• Recall Event ID: 78888
• PMA Number: P010031S550 P010031S513
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: ; a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); ; b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ); ; Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
• Code Information: a. Product No. DTMC1D1: UDI 00643169705807 (Serial No. RPW200289H); b. Product No. DTMC1QQ: UDI 00643169565272 (Serial No. RPL201034H) (EXPANSION: Serial No. RPL200052H, RPL200534H, RPL201039H, RPL201059H, RPL201235H, RPL201236H, RPL201454H, RPL201645H, RPL201664H, RPL201234H)
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: 800-723-4636
• Manufacturer Reason for Recall: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
• FDA Determined 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 800-551-5544 (Monday-Friday, 8am-5pm Central Time). The recall was expanded on 03/15/2018 and customers were notified by letter. Affected product, not yet implanted, was retrieved on about 03/08/2018. Instructions in the physicians following patients implanted with the additional affected devices included prophylactic device replacement for those patients at higher risk, including patients whose clinical history indicates prior need for high-voltage therapy and/or for pacemaker-dependent patients. The physicians should carefully weigh the risks and benefits of device replacement. If it is determined that replacement is not warranted, instructions included the following: programming changes to reduce the potential for high-voltage charges associated with arrhythmia detection and therapies, such as enabling ATP before charging for fast ventricular rhythms or programming a separate fast VT via VF zone with ATP; Continue three-month in-clinic or remote follow-ups to verify device functionality because inability to interrogate a device or a failed remote monitoring transmission may be an indication that internal arcing has occurred; and to advice patients to seek medical attention immediately if they experience new or unexpected symptoms suspicious for a ventricular arrhythmia. Medtronic Patient Services is available to assist patients at 800-551-5544 (Monday-Friday, 8am-5pm Centra
• Quantity in Commerce: 951 devices total
• Distribution: US Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.