1. Postmarket Surveillance of Medical Device Adverse Events Hesha Jani Duggirala, PhD Epidemiology Branch Division of Postmarket Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological Health

2. CDRH Background Center for Devices and Radiological Health Ensuring the safety and effectiveness of medical devices

3. Postmarket Surveillance Activities Medical Device Reporting (MDR) system Data mining Medical Product Surveillance Network (MedSun)

4. MDR Reporting Nationwide passive surveillance system Device death, serious injuries, and malfunctions Reports submitted by manufacturers, user facilities, and voluntary reporters (including patients, healthcare providers, and consumers)

5. MDR Reporting Device information Patient information Procedure information

6. MDR Reporting Review of data Individual reports Aggregate data

7. Limitations of MDR Underreporting Incomplete, non-validated data No incidence data Uncertain causality Biased reporting

8. Data Mining at CDRH Working with Lincoln Technologies webVDME program Drug-eluting stents test case

9. MedSun Medical Product Surveillance Network Report deaths, serious injuries, near misses

10. Additional Information MDR: www.fda.gov/cdrh/mdr Search MDR online: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/Se arch.cfm MedSun: www.medsun.net/about.html Reach me: hcj@cdrh.fda.govwww.medsun.net/about.html