Sprint Fidelis (defibrillator)

2019: Medtronic agreed with U.S. authorities to hide data on tens of thousands of complaints to the rejected defibrillators

At the end of May, 2019 the non-profit news agency Kaiser Health News specializing in illumination of problems in the field of health care published the report according to which Medtronic agreed with U.S. authorities to hide data on tens of thousands of complaints to the rejected defibrillators.

In ten years which passed from release of a defibrillator of Sprint Fidelis Medtronic received 37 thousand claims, beginning from sudden operations (2,898 messages) before discrepancy of contacts (22,093 messages). Though Medtronic recalled the device from the market, the general public did not know about these claims until Kaiser Health News published the report on 37,000 complaints of patients which were detected in public base of the Food and Drug Administration (FDA) - MAUDE.

Medtronic agreed with FDA to hide messages about the rejected defibrillators

The official representative of Medtronic Jeffrey Trauring said that since 2007 the company regularly publishes reports for medical community in which it provides the latest data on the frequency of failures in operation of devices. The representative published the similar comment, having noted that reports on efficiency of products of Medtronic are published two times a year more than 15 years.

However in the federal law obliging to provide the companies such reports there is a hole. Though producers should enter information on failures in operation of the device, the serious undesirable phenomena and lethal cases in a public database of regulatory bodies, the companies have the right to keep aggregated data of reports on the undesirable phenomena in secret. This amendment was made to the law as at the correct description of the undesirable phenomenon summary reports were considered excessive.

Summary reports technically still are the public information available during a month, but that to see them, it is necessary to know about their existence. Information on summary reports is dirtied from public reports of MAUDE for a long time though Star Tribune in 2016 convinced FDA to publish earlier unknown data covering hundreds of thousands of undesirable phenomena which were connected with experimental use of the device for gain of growth of bones of Infuse (also productions of Medtronic).

Medtronic could hide tens of thousands of complaints about the rejected defibrillators, and the regulator closed eyes to it

The subsequent researches showed that Medtronic was one of the most frequent users of a system of the summary reporting: from 2007 to 2015 they submitted 46 reports covering about 6,399 events to the period. But in one of them it is not mentioned about 37,000 messages describing more than 50,000 problems of the rejected Sprint Fidelis cardiodefibrillator.

Medtronic states that separate reports on the undesirable phenomena are not so significant as information for doctors which contains in corporate statements about devices. The matter is that registration of messages about the undesirable phenomena in MAUDE does not mean yet that specialists confirmed communication between failure of the device and emergence of a problem. Nevertheless, it is more profitable to producers to make summary reports, than to sort each message as it allows them not to make public information.

During the period from 2004 to 2007 around the world Medtronic sold more than 260,000 Sprint Fidelis devices. About 74% of kardiofibrillyator of Sprint Fidelis registered in the USA remained in operation in 10 years after Medtronic voluntarily recalled these devices from the market.

Officials of regulatory bodies said that they are going to refuse completely the program under the name "alternative summary reporting" at the end of 2019 and to start service under the name Device Events which will study reports on the undesirable phenomena.^[1]

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