June 06, 2020

Device for heart linked to deaths

A consumer group said Thursday that the Food and Drug Administration had received 322 reports of deaths in a 15-month period that were associated with defects in an electric defibrillator device. The devices, made by the Physio-Control Corp., are used to deliver a shock to revive patients after a heart attack.

The group, the Public Citizen Health Research Group, said the agency received 1,000 reports of defects in the devices from Jan. 1, 1992 to March 31, 1993, including those involving deaths.

Joanne C. Mott, a reseacher with the group in Washington, said the federal agency’s records showed that it had allowed the company to resume making defibrillators on May 18, after a 10-month suspension, although reports of defective devices were still being received.

Dr. Sidney M. Wolfe, director of the research group, and Ms. Mott asked the FDA commissioner, Dr. David A. Kessler, to bring criminal charges against Physio-Control, a subsidiary of Eli Lilly & Co. They said the company had showed “reckless disregard” of the agency’s regulations.

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