MEDTRONIC INC

PACEART · Gastroenterology and Urology

510(k): 1 Recall: 2 UDI: 21 MAUDE: 10 Class.: 0

510(k) Clearances (1)

2011-06-08

Substantially Equivalent

Recalls (2)

Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker e

2007-08-27

An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used

2006-02-02

The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.

UDI Registrations (21)

PACEART® SYSTEM GET CONNECTED III

SW PASCLGCIII PACEART GLBL MR GCIII

PACEART OPTIMA™ System

SW POS12D15 MKT GLBL

PACEART® SYSTEM GET CONNECTED III, CardioVoice® TTM Assistant Software

SW PASCVGCIII PACEART GLBL MR GCIII

PACEART® SYSTEM ECG MODULE

ECG P127TUV PACEART SYSTEM FW 1.09 GLBL

PACEART® SYSTEM GET CONNECTED III

SW PASDEVUGCIII PACEART GLBL MR V 2.0

PACEART® SYSTEM GET CONNECTED III

SW PASEXPGCIII PACEART GLBL MR GCIII

PACEART OPTIMA™ SYSTEM

SW POS12D18 OPTIMA 1.8 GLOBAL

PACEART® SYSTEM GET CONNECTED III

SW PASDEVU3 DEV UPDATE MKT GLBL

PACEART® SYSTEM GET CONNECTED III

SW PASDEMOGCIII PACEART GLBL MR GCIII

PACEART® SYSTEM GET CONNECTED III

SW PASGATEGCIII PACEART GLBL MR GCIII

PACEART OPTIMA™ SYSTEM

SW POS12D17 OPTIMA 1.7 GLOBAL

PACEART® SYSTEM GET CONNECTED III

SW PASSATGCIII PACEART GLBL MR GCIII

Paceart Optima™ System 1.6 with Analytics

SW POS12D16A OPTIMA 1.6 WITH ANALYTICS

PACEART OPTIMA™ System

SW POS12D14 PACEART OPTIMA MKT GLBL

PACEART OPTIMA™ System

SW POS12D13 PACEART OPTIMA MKT GLBL

PACEART OPTIMA™ SYSTEM

SW POS12D16 MKT GLBL

PACEART® SYSTEM GET CONNECTED III

SW PASTCGCIII PACEART GLBL MR GCIII

PACEART OPTIMA™ SYSTEM

SW POS12D17 OPTIMA 1.7 GLOBAL

PACEART OPTIMA™ System

SW POS12D13 PACEART OPTIMA MKT GLBL

PACEART® SYSTEM GET CONNECTED III

SW PASDOCGCIII PACEART GLBL MR GCIII

PACEART® SYSTEM GET CONNECTED III

SW PASTMGCIII PACEART GLBL MR GCIII

MAUDE Adverse Events (10)

Malfunction

20210817

Malfunction

20210713

Malfunction

20210706

Malfunction

20210629

Malfunction

20210625

Malfunction

20210608

Malfunction

20210309

Malfunction

20210111

Malfunction

20200727

Malfunction

20200115