MAUDE MDR 9908801

MDR report key: 9908801
Report number: 2182208-2020-00638
Event key: 0
Event type: 3
Date of event: 2020-03-19
Date received: 2020-03-31
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	CARELINK PROGRAMMER	PROGRAMMER, PACEMAKER	MEDTRONIC, INC.	KRG	2090	2090					*	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-31	0

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT THE PROGRAMMER HAD A PROBLEM WITH STYLUS CALIBRATION, BEING AN INCH OFF. IT WAS RECOMMENDED THAT THE DEVICE BE RETURNED FOR SERVICE AND TO TRY A DIFFERENT STYLUS. THE DEVICE IS TO BE RETURNED FOR SERVICE. THERE WAS NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

N

Patient 1

ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMERS REPORTED STYLUS CALIBRATION ISSUE. THE "XY/OVERLAY CABLE" WAS RESEATED AND THE STYLUS WAS CALIBRATED. BROKEN TABS ON THE POWER CORD BAY DOOR WERE NOTED. THE POWER CORD BAY WAS REPLACED. THE BROKEN LEFT KEYBOARD HINGE WAS FOUND TO BE BROKEN AND WAS REPLACED. HARD DRIVE WAS RECONFIGURED, RELOADED AND UPDATED WITH THE APPROPRIATE SOFTWARE. THE PROGRAMMER PASSED ALL FINAL FUNCTION AND SYSTEM TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS FURTHER REPORTED THAT THE STYLUS DID NOT WORK IN THE BOTTOM RIGHT OF THE SCREEN. THE DEVICE WAS RETURNED FOR SERVICE. IT HAS BEEN FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04035479001575	M-50	BIOTRONIK SE & Co. KG	KRG	2024-10-16
00763000842536	NA	MEDTRONIC, INC.	KRG	2023-11-11
20763000842530	NA	MEDTRONIC, INC.	KRG	2023-11-11
00763000181185	NA	MEDTRONIC, INC.	KRG	2023-01-30
04035479176112	DataBridge NA	BIOTRONIK SE & Co. KG	KRG	2022-12-14
00763000059545	Viva™ XT CRT-D	MEDTRONIC, INC.	KRG	2017-10-21
00763000059651	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	KRG	2017-10-21
00763000059668	Viva™ XT CRT-D	MEDTRONIC, INC.	KRG	2017-10-21
00643169720138	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720145	Viva™ Quad S CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720190	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720206	Viva™ Quad S CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720251	Viva™ XT CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720268	Viva™ S CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720312	Viva™ XT CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169720329	Viva™ S CRT-D	MEDTRONIC, INC.	KRG	2017-09-15
00643169929319	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	KRG	2017-05-22
00643169929371	Viva™ S CRT-D	MEDTRONIC, INC.	KRG	2017-05-22
00643169929388	Viva™ S CRT-D	MEDTRONIC, INC.	KRG	2017-05-22
00643169929395	Viva™ Quad S CRT-D	MEDTRONIC, INC.	KRG	2017-05-22
00643169929296	Viva™ XT CRT-D	MEDTRONIC, INC.	KRG	2017-05-14
00643169929302	Viva™ XT CRT-D	MEDTRONIC, INC.	KRG	2017-05-14
00643169929326	Viva™ Quad XT CRT-D	MEDTRONIC, INC.	KRG	2017-05-14
00643169929401	Viva™ Quad S CRT-D	MEDTRONIC, INC.	KRG	2017-05-14
05414734500449	SJM™	ST. JUDE MEDICAL, INC.	KRG	2017-04-10
05414734006880	Identity™	ST. JUDE MEDICAL, INC.	KRG	2017-02-06
05414734006774	Verity™	ST. JUDE MEDICAL, INC.	KRG	2017-02-03
05414734006811	Verity™	ST. JUDE MEDICAL, INC.	KRG	2017-02-03
05414734006835	Verity™	ST. JUDE MEDICAL, INC.	KRG	2017-02-03
05414734006842	Verity™	ST. JUDE MEDICAL, INC.	KRG	2017-02-03

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K933278	KRG	INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04	Intermedics, Inc.	1995-03-15
510(k)	K884522	KRG	MODEL 5650 OPTIMATE PERSONAL PROGRAMMER	Teletronics, Inc.	1989-08-25
510(k)	K880738	KRG	MODEL 2331T PATIENT PROGRAMMER	Medtronic Vascular	1988-11-17
510(k)	K882429	KRG	MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004	Tpl-Cordis, Inc.	1988-07-22
510(k)	K864712	KRG	MODEL 1740 PERSONAL POCKET PROGRAMMER	Telectronics, Inc.	1987-12-17
PMA	P010031S511	KRG	BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D	Medtronic Cardiac Rhythm Disease Management	2015-10-29
PMA	P010031S500	KRG	APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC	Medtronic Cardiac Rhythm Disease Management	2015-06-04
PMA	P010031S413	KRG	BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE	Medtronic Cardiac Rhythm Disease Management	2014-02-27
PMA	P890003S253	KRG	MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS	Medtronic, Inc.	2013-01-29
PMA	P880086S108	KRG	VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610	ABBOTT MEDICAL	2005-12-07

MAUDE MDR 9908801

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

N

D

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