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FDA > CDRH > FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008

FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008

Date, Time and Location
Registration
Final Agenda
Contacts

Date, Time and Location

The meeting will be held on October 2, 2008, from 8:00 a.m. to 5 p.m., and on October 3, 2008, from 8:00 a.m. to 12:00 p.m. at the following location:

Hilton Washington DC North / Gaithersburg
620 Perry Parkway,
Gaithersburg, Maryland, 20877
(301) 977-8900

Registration

Online registration is now closed.

Final Agenda

Thursday, October 2, 2008

7:45 AM	Arrive at Gaithersburg Hilton Registration / Check-in
8:00 AM	Welcome and Introduction Megan Moynahan, FDA Center for Devices and Radiological Health Jonathan Sackner-Bernstein, MD, Associate Center Director for Postmarket Operations, FDA Center for Devices and Radiological Health
8:30 AM	Topic 1: Clinical Diagnosis of ICD and Pacemaker Lead Problems FDA Perspective Brian Lewis, MD, FACC, FDA/CDRH/Office of Device Evaluation Industry Perspective Arjun Sharma, MD, VP Patient Safety, Cardiac Rhythm Management, Boston Scientific Heart Rhythm Society Perspective Andrew Krahn, MD, Associate Professor of Cardiology, University of Western Ontario, University Hospital Q&A Session
9:15 AM	Topic 2: Returned Product Analysis FDA Perspective Mark Fellman, FDA/CDRH/Office of Device Evaluation Industry Perspective Philip Tsung, Sr Director, Quality Assurance, St Jude Medical Heart Rhythm Society Perspective Bruce Wilkoff, Director of Cardiac Pacing, Cleveland Clinic Q&A Session
10:00 AM	Break
10:15 AM	Topic 3: Adverse Event Reporting FDA Perspective Roberta Sullivan, MDR Analyst, FDA/CDRH/Office of Surveillance and Biometrics Industry Perspective Jon Brumbaugh, VP Regulatory Affairs and Compliance, Biotronik Heart Rhythm Society Perspective William H. Maisel, MD, Director, Medical Device Safety Institute, Beth Israel Deaconess Medical Center CV Division Q&A Session
11:00 AM	Topic 4: Post-Approval Studies, Registries and Home Monitoring FDA Perspective Danica Marinac-Dabic, MD, Ph.D., MMSc, Chief, Epidemiology Branch, FDA/CDRH/Office of Surveillance and Biometrics Industry Perspective Tim Samsel, VP Quality and Regulatory Affairs, Medtronic Heart Rhythm Society Perspective William H. Maisel, MD, Director, Medical Device Safety Institute, Beth Israel Deaconess Medical Center CV Division Q&A Session
11:45 AM	Instructions for Breakout Sessions
12:00 noon	Lunch
1:20 PM	BREAKOUT SESSIONS Topic #1: Clinical Diagnosis of Pacemaker and ICD Lead Problems Facilitators: Mitchell Shein, FDA; Arjun Sharma, Boston Scientific Topic #2: Returned Product Analysis Facilitators: Mark Fellman, FDA; Melissa Torres, FDA; Philip Tsung, St Jude Medical. Topic #3: Adverse Event Reporting Facilitators: Roberta Sullivan, FDA; Terrie Reed, FDA; Jon Brumbaugh, Biotronik Topic #4: Postapproval Studies, Registries, Home Monitoring Facilitators: Hesha Duggirala, FDA; Tom Gross, FDA; Tim Samsel, Medtronic
3:00 PM	Break
3:15 PM	Resume Breakout Sessions
5:00 PM	Adjourn from Breakout Sessions

Friday, October 3, 2008

8:10 AM	Introduction for Day 2 Megan Moynahan, FDA Center for Devices and Radiological Health
8:30 AM	Best Practices Report, Topic 1: Clinical Diagnosis of Lead Problems Mitchell Shein, FDA Q&A Session
9:15 AM	Best Practices Report, Topic 2: Returned Product Analysis Mark Fellman, FDA Q&A Session
10:00 AM	Break
10:15 AM	Best Practices Report, Topic 3: Adverse Event Reporting Roberta Sullivan, FDA Q&A Session
11:00 AM	Best Practices Report, Topic 4: Postmarket Studies, Registries, Home Monitoring Tim Samsel, Medtronic Q&A Session
11:45 AM	Wrap-Up
12:00 PM	Adjourn

Contacts

The workshop organizers may be contacted at:
Megan Moynahan
Network Leader, Cardiac Electrophysiology and Monitoring Network
Office of the Center Director, CDRH
Food and Drug Administration
7520 Standish Place, HFZ-4
Rockville, MD 20855
Phone: (240) 276-8707
Fax: (240) 276-8855
e-mail: megan.moynahan@fda.hhs.gov

Mark Fellman
Scientific Reviewer
Division of Cardiovascular Devices
Office of Device Evaluation, CDRH
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: (240) 276-4060
Fax: (240) 276-4002
e-mail: mark.fellman@fda.hhs.gov

Updated September 26, 2008

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