MAUDE MDR 4241433

MDR report key: 4241433
Report number: 2183959-2014-00502
Event key: 0
Event type: 3
Date of event: 2014-09-09
Date received: 2014-11-10
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: MRS. SHARON ZURN
Address: 10700 BREN ROAD W MINNETONKA MN 55343 US
Phone: 952-952-9529
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	AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY	SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY	AMERICAN MEDICAL SYSTEMS (MN)	MEQ		72404311R					Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2014-11-10	0	1. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE CONSOLE TEMPERATURE WENT BEYOND THE PRESCRIBED TEMPERATURE AND CAUSED DISCOMFORT TO THE PATIENT. IT WAS ALSO INDICATED THAT SOME PATIENTS NEEDED A CATHETER TO BE INSERTED AFTER TREATMENT DUE TO URINARY RETENTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

N

Patient 1

THE CONSOLE IN QUESTION WAS RETURNED FOR EVALUATION. ANALYSIS RESULTS INDICATE THE CONSOLE PERFORMED WITHIN SPECIFICATION.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07350081910013	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910020	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910037	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910044	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910051	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910068	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910075	CoreTherm	Prostalund AB	MEQ	2016-03-07
07350081910082	CoreTherm	Prostalund AB	MEQ	2016-03-07
M876PT10340	Targis	Urologix LLC	MEQ	2014-09-26
M876PT10360	Targis	Urologix LLC	MEQ	2014-09-26
M876PT10380	Targis	Urologix LLC	MEQ	2014-09-26
M876RB3131A1	Targis	Urologix LLC	MEQ	2014-09-26
M876RB3131A2	Targis	Urologix LLC	MEQ	2014-09-26

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P010055S011	MEQ	ProstaLund CoreTherm System Microwave Thermotherapy for BPH	Prostalund AB	2021-06-30
PMA	P030006S028	MEQ	Prolieve Thermodilation System	Medifocus, Inc.	2018-11-21
PMA	P970008S065	MEQ	UROLOGIX TARGIS SYSTEM	Urologix, LLC	2015-10-29
PMA	P970008S064	MEQ	UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH	Urologix, LLC	2015-08-28
PMA	P030006S027	MEQ	PROLIEVE THERMODILATATION SYSTEM	Medifocus, Inc.	2014-12-16

MAUDE MDR 4241433

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#