IMPROVE OUTCOMES | REDUCE RISK

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IMPROVE OUTCOMES | REDUCE RISK

Device-Events-638x150

IMPROVE OUTCOMES | REDUCE RISK

FDA releases millions of records of incidents involving medical devices

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June 21, 2019 – Star Tribune – The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.

The roughly 6 million reports released Friday cover a wide array of devices in reports that were secretly filed with the FDA from 1999 to April of this year. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants and heart monitors to pediatric breathing machines. Device makers with Minnesota ties in the data include Boston Scientific, Coloplast, Medtronic and the former St. Jude Medical.

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