—#161073

Product

Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Evera XT DR ICD DF4 (Product No. DDBB1D4) 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: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980016S382
Affected lot / code info: a. Product No. DDBC3D1: UDI 00643169018044 (Serial No. BWG204574H) (EXPANSION: Serial No. BWG200861H, BWG201119H, BWG201913H, BWG204028H, BWG204300H, BWG205740H, BWG205936H, BWG206156H, BWG206745H, BWG206747H, BWG206882H, BWG206883H, BWG206884H, BWG206885H, BWG207389H, BWG207390H); b. Product No. DVBC3D1: UDI 00643169929852 (Serial No. BWM204635H), 00643169017900 (Serial No. BWM204192H) (EXPANSION: Serial No. BWM201169H, BWM202293H, BWM203256H, BWM203852H, BWM200338H, BWM203851H, BWM204508H); c. Product No. DVBC3D4: UDI 00643169017887 (Serial No. BWL204405H) (EXPANSION: Serial No. BWL202873H, BWL203306H, BWL203955H, BWL205870H, BWL201180H, BWL202937H, BWL205860H); d. Product No. DDBB1D1: UDI 00643169018099 (Serial No. BWC223253H, BWC201978H), 00643169530263 (Serial No. BWC233374H, BWC234767H, BWC234772H) (EXPANSION: Serial No. BWC236143H, BWC214218H, BWC201100H, BWC203011H, BWC203472H, BWC204674H, BWC205108H, BWC206553H, BWC206785H, BWC207821H, BWC207822H, BWC207823H, BWC210629H, BWC212493H, BWC214272H, BWC214763H, BWC216241H, BWC217842H, BWC217843H, BWC217844H, BWC218221H, BWC218224H, BWC224331H, BWC226302H, BWC226305H, BWC226657H, BWC227492H, BWC227493H, BWC228308H, BWC228309H, BWC228351H, BWC228836H, BWC229030H, BWC229087H, BWC231807H, BWC231876H, BWC231928H, BWC232958H, BWC234187H, BWC234515H, BWC234517H, BWC234518H, BWC234519H, BWC234522H, BWC234525H, BWC234559H, BWC234722H, BWC235087H, BWC235655H, BWC235967H, BWC235968H, BWC235969H, BWC236085H, BWC236087H, BWC236140H, BWC236141H, BWC236142H, BWC236144H, BWC236182H, BWC236290H, BWC236722H, BWC236723H, BWC236724H, BWC236775H, BWC237274H, BWC238797H, BWC239432H, BWC239866H, BWC216082H, BWC218086H, BWC224128H), 00643169929111 (Serial No. BWC240255H, BWC241043H); e. Product No. DVBB1D1: UDI 00643169017955 (Serial No. BWI208876H) (EXPANSION: Serial No. BWI209212H, BWI200678H, BWI200679H, BWI200980H, BWI202079H, BWI204182H, BWI204201H, BWI206252H, BWI208151H, BWI209159H, BWI209879H, BWI212202H, BWI214590H, BWI215505H, BWI215752H, BWI216623H, BWI216981H, BWI217952H, BWI217739H, BWI217941H, BWI218177H, BWI211281H, BWI217953H, BWI217955H); f. Product No. DVBB1D4: UDI 00643169017948 (Serial No. BWH201158H, BWH214640H) (EXPANSION: Serial No. BWH203008H, BWH203759H, BWH207797H, BWH209311H, BWH209313H, BWH210341H, BWH211052H, BWH211053H, BWH212583H, BWH212739H, BWH212740H, BWH213523H, BWH213531H, BWH214545H, BWH214546H, BWH217150H, BWH217312H, BWH218316H, BWH218386H, BWH219837H, BWH220818H, BWH221001H, BWH222521H, BWH224286H, BWH224297H, BWH223806H); EXPANSION: g. Product No. DDBC3D4: UDI 00643169018020 (Serial No. BWF200823H, BWF204395H, BWF206087H, BWF201831H, BWF202542H, BWF205758H, BWF201407H, BWF203531H, BWF205759H, BWF205852H); h. Product No. DDBB1D1G: UDI 00643169777606 (Serial No. BWC235910H); i. Product No. DDBB1D4: UDI 00643169018082 (Serial No. BWB206139H, BWB218529H, BWB201323H, BWB202548H, BWB202741H, BWB203522H, BWB203524H, BWB203525H, BWB203527H, BWB203528H, BWB203529H, BWB204481H, BWB205332H, BWB206095H, BWB206099H, BWB206476H, BWB207118H, BWB210704H, BWB212480H, BWB212482H, BWB212577H, BWB217513H, BWB218439H, BWB218616H, BWB218957H, BWB220702H, BWB221924H, BWB222431H, BWB223026H, BWB223413H, BWB224318H, BWB227088H, BWB229740H, BWB230009H, BWB230011H, BWB230116H, BWB203526H, BWB211923H, BWB229726H)

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 #161073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.