MAUDE MDR 9391936

MDR report key: 9391936
Report number: 2182208-2019-02150
Event key: 0
Event type: 3
Date of event: 2019-10-30
Date received: 2019-11-29
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 3
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: PAULA BIXBY
Address: 8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone: 763-763-7635
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	DUAL CHAMBER TEMPORARY PACEMAKER	PULSE-GENERATOR, PACEMAKER, EXTERNAL	MEDTRONIC, INC.	DTE	5392	5392					Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00850056280020	SoloPace EPG	SOLO PACE INC.	DTE	2026-02-02
00850056280013	Solo Pace Control System	SOLO PACE INC.	DTE	2025-01-23
00850056280037	Solo Pace Control System	SOLO PACE INC.	DTE	2025-01-23
04260451441050	CARDIOTRONIC	Osypka Medical GmbH	DTE	2021-04-30
04260451441067	CARDIOTRONIC	Osypka Medical GmbH	DTE	2021-04-30
04260451441173	Osypka Medical	Osypka Medical GmbH	DTE	2021-04-30
00763000162443	NA	MEDTRONIC, INC.	DTE	2018-11-11
00643169723160	NA	MEDTRONIC, INC.	DTE	2017-03-12
00643169725126	NA	MEDTRONIC, INC.	DTE	2017-01-29
00847946021986	HWD Electrode Set	Zoll Medical Corporation	DTE	2016-10-20
00885672005467	PACE 203H	Oscor Inc.	DTE	2016-09-17
04260451441012	CARDIOTRONIC	Osypka Medical GmbH	DTE	2016-09-13
04260451441029	CARDIOTRONIC	Osypka Medical GmbH	DTE	2016-09-13
00836559008859	PACE 101H	Oscor Inc.	DTE	2016-09-09
00836559008866	PACE 203H	Oscor Inc.	DTE	2016-09-09
00643169382978	5391	Oscor Inc.	DTE	2016-09-09
00847946021191	PRO PADZ	Zoll Medical Corporation	DTE	2016-08-03
00847946016661	PRO PADZ	Zoll Medical Corporation	DTE	2015-10-21
00643169508767	NA	MEDTRONIC, INC.	DTE	2014-11-13
00847946016401	PRO PADZ	Zoll Medical Corporation	DTE	2014-09-24
00847946016463	PRO PADZ	Zoll Medical Corporation	DTE	2014-09-24
00643169230859	NA	MEDTRONIC, INC.	DTE	2014-09-23
00643169305120	NA	MEDTRONIC, INC.	DTE	2014-09-23
04035479010355	PK-67-L/2,6m	BIOTRONIK SE & Co. KG	DTE	2014-08-20
04035479015473	PK-67-S/0,8m	BIOTRONIK SE & Co. KG	DTE	2014-08-20
04035479049300	PK-175/2,3m	BIOTRONIK SE & Co. KG	DTE	2014-08-19
04035479079581	PK-83-B/2,5m	BIOTRONIK SE & Co. KG	DTE	2014-08-19
04035479080228	PK-83-B/1,5m	BIOTRONIK SE & Co. KG	DTE	2014-08-19

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K241781	DTE	Solo Pace Control	Solo Pace, Inc.	2025-01-10
510(k)	K232721	DTE	Lifetech Cardio Temporary Pacemaker	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.	2024-01-07
510(k)	K201011	DTE	Medtronic Model 5392 External Pulse Generator (EPG)	Medtronic, Inc.	2020-05-13
510(k)	K190825	DTE	Medtronic Model 5392 External Pulse Generator (EPG)	Medtronic, Inc.	2019-04-30
510(k)	K182839	DTE	Lifetech Cardio Model 8301 Temporary Pacemaker	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.	2019-02-28
PMA	P920032S008	DTE	MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER	Pace Medical	2002-02-20
PMA	P920032S007	DTE	BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170	Pace Medical	2001-10-26
PMA	P920032S006	DTE	MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER	Pace Medical	2001-04-06

MAUDE MDR 9391936

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#