MAUDE MDR 9392348

MDR report key: 9392348
Report number: 2124215-2019-24451
Event key: 0
Event type: 3
Date of event: 2019-06-25
Date received: 2019-11-30
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: TIMOTHY DEGROOT
Address: 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US
Phone: 651-651-6515
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	DYNAGEN X4 CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D	BOSTON SCIENTIFIC CORPORATION	NIK	G158	G158	155255				R	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-30	0	1. H; 2. L; 3. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04035479182809	Acticor Sky HF-T QP	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479182816	Acticor Sky HF-T	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479182854	Rivacor Sky HF-T QP	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479182861	Rivacor Sky HF-T	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479182984	Rivacor Aura HF-T QP	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479182991	Rivacor Aura HF-T	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479183028	Rivacor Rise HF-T QP	BIOTRONIK SE & Co. KG	NIK	2026-04-20
04035479183035	Rivacor Rise HF-T	BIOTRONIK SE & Co. KG	NIK	2026-04-20
05414734509138	NA	ST. JUDE MEDICAL, INC.	NIK	2026-03-04
05414734506380	NA	ST. JUDE MEDICAL, INC.	NIK	2025-12-22
05415067049575	Merlin™	ST. JUDE MEDICAL, INC.	NIK	2025-06-25
05415067050045	Neutrino™	ST. JUDE MEDICAL, INC.	NIK	2025-02-11
05415067050052	Gallant™	ST. JUDE MEDICAL, INC.	NIK	2025-02-11
05415067050076	Neutrino™	ST. JUDE MEDICAL, INC.	NIK	2025-02-11
05415067050090	Gallant™	ST. JUDE MEDICAL, INC.	NIK	2025-02-11
05415067050106	Entrant™	ST. JUDE MEDICAL, INC.	NIK	2025-02-11
05415067050120	Entrant™	ST. JUDE MEDICAL, INC.	NIK	2025-02-11
05415067034809	Merlin@home™	ST. JUDE MEDICAL, INC.	NIK	2024-11-13
05415067049513	Entrant™	ST. JUDE MEDICAL, INC.	NIK	2024-04-25
05415067049520	Gallant™	ST. JUDE MEDICAL, INC.	NIK	2024-04-25
05415067040404	NA	ST. JUDE MEDICAL, INC.	NIK	2023-01-09
05415067031174	Merlin™	ST. JUDE MEDICAL, INC.	NIK	2022-08-29
05415067037121	Merlin™	ST. JUDE MEDICAL, INC.	NIK	2022-08-29
00802526589744	RESONATE™ HF CRT-D	BOSTON SCIENTIFIC CORPORATION	NIK	2021-07-12
05415067032812	myMerlinPulse™	ST. JUDE MEDICAL, INC.	NIK	2021-01-07
05415067032829	myMerlinPulse™	ST. JUDE MEDICAL, INC.	NIK	2021-01-07
00763000178093	Cobalt™ XT HF Quad CRT-D MRI SureScan™	MEDTRONIC, INC.	NIK	2020-11-22
00763000178109	Cobalt™ XT HF Quad CRT-D MRI SureScan™	MEDTRONIC, INC.	NIK	2020-11-22
00763000178130	Cobalt™ XT HF CRT-D MRI SureScan™	MEDTRONIC, INC.	NIK	2020-11-22
00763000178147	Cobalt™ XT HF CRT-D MRI SureScan™	MEDTRONIC, INC.	NIK	2020-11-22

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P010031S932	NIK	Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D	Medtronic Cardiac Rhythm Disease Management	2026-09-25
PMA	P010012S612	NIK	Tachy Pulse Generators	Boston Scientific Corp	2026-08-25
PMA	P030054S446	NIK	Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q,	ABBOTT MEDICAL	2026-08-12
PMA	P010031S930	NIK	Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) Brava Quad	Medtronic Cardiac Rhythm Disease Management	2026-07-31
PMA	P010031S929	NIK	Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR	Medtronic Cardiac Rhythm Disease Management	2026-07-31

MAUDE MDR 9392348

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#