MAUDE MDR 587324

MDR report key: 587324
Report number: 2184009-2005-00024
Event key: 0
Event type: 3
Date of event: 2005-03-07
Date received: 2005-03-25
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: LISA WEIK
Address: 8299 CENTRAL AVE NE MINNEAPOLIS MN 55432 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	MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE	VACUUM RELIEF VALVE	MEDTRONIC PERFUSION SYSTEMS	MNJ	VRV-100	3R93R2	UNK		K953564	N	R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2005-03-25	0	1. R

Event Narratives#

D

Patient 1

UNIT LEAKED DURING THE PROCEDURE AND WAS CHANGED OUT. THE PRODUCT WAS REPLACED DURING BYPASS WITH NO PATIENT COMPLICATION REPORTED OTHER THAN A MINIMAL BLOOD LOSS OF APPROXIMATELY 5 CC'S NOTED.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K992964	MNJ	IBC VENT VALVE, MODEL 1400	International Biophysics Corp.	1999-11-19
510(k)	K941492	MNJ	PRESSURE RELIEF VALVE	Circulatory Technology, Inc.	1994-10-26