—#160853

Product

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) 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).

FDA product code: NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010031S513, P010031S550
Affected lot / code info: a. Product No. DTMA1D1: UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H); b. Product No. DTMA1QQ: UDI 00643169543362 (Serial No. RPA202057H) (EXPANSION: Serial No. RPA200224H, RPA200472H, RPA200673H, RPA201732H, RPA201733H, RPA202258H, RPA202454H, RPA202455H, RPA202649H, RPA202650H, RPA202651H, RPA202652H, RPA202653H, RPA203381H, RPA203416H, RPA203546H, RPA203547H, RPA204428H, RPA204605H, RPA204606H, RPA201333H, RPA202259H), 00643169929562 (Serial No. RPA204495H); EXPANSION: c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H); d. Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H)

Why it was recalled

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2017-12-19
Posted by FDA: 2018-02-01
Terminated: 2021-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160853. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.