MAUDE MDR 3131026

MDR report key: 3131026
Report number: 2183502-2013-00236
Event key: 0
Event type: 3
Date of event: 2013-04-12
Date received: 2013-05-20
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: PETE HIRTE
Address: 1265 GREY FOX ROAD ST. PAUL MN 55112 US
Phone: 651-651-6516
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	PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCCESS SYSTEM	LNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL	SMITHS MEDICAL MD	LNY	21-1500	21-1500-22	UNK				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-05-20	0	1. R

Event Narratives#

D

Patient 1

FROM CLINICAL TRIAL STUDY ORGANIZER: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN PT FOR ADMINISTRATION OF CLINICAL TRIAL DRUG (DATE NOT PROVIDED). ACCORDING TO RPTR THE DEVICE "FAILED" AND DEVICE WAS EXPLANTED FROM PT AS A RESULT. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED. ADD'L INFO HAS BEEN REQUESTED REGARDING THE EVENT; THIS INFO HAS NOT BEEN REC'D AT THIS TIME.

N

Patient 1

CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
10610586013225	Deltec	ICU MEDICAL, INC.	LNY	2014-09-21
10610586013355	Deltec	ICU MEDICAL, INC.	LNY	2014-09-21

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P900052S018	LNY	PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM	Smiths Medical Asd, Inc.	2013-05-13
PMA	P900052S017	LNY	PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM	Smiths Medical Asd, Inc.	2010-04-21
PMA	P900052S016	LNY	PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM	Smiths Medical Asd, Inc.	2009-04-20
PMA	P900052S015	LNY	PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM	Smiths Medical Asd, Inc.	2007-11-06
PMA	P900052S014	LNY	PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS	Smiths Medical Asd, Inc.	2007-08-28

MAUDE MDR 3131026

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#