US medical technology company Medtronic may be linked to as many as 9,300 deaths in the US alone, in addition to an estimated 292,000 injuries, according to a report published Sunday.
According to the document, compiled by the International Consortium of Investigative Journalists (ICIJ), in 2017, one in five of overall medical device adverse event reports was tied to a Medtronic device, which is more than twice as many as the company's rivals, like Johnson & Johnson, Abbott Laboratories and Boston Scientific. All the aforementioned companies, including Medtronic, said they conduct business with the highest ethical standards, in keeping with all laws, and have comprehensive programs to prevent employee misconduct. Medtronic, meanwhile, hasn't yet independently researched and verified the cited statistical data.
The report, entitled "The Implant Files," which studied data in 36 countries, revealed that authorities in Japan and Norway have also named Medtronic as the single largest source of medical complaints over the past five years.
While the ICIJ report credits the development of live-saving products, it also says that the company has "pushed against or broken legal and ethical boundaries."
Families of victims in Finland, Germany, Canada, India and the US have reported that Medtronic was remarkably slow in replying to questions regarding potential problems with their production and sometimes did not bother to inform people about possible risks.
The US Food and Drug Administration commented on the report, saying that since Medtronic is the largest producer of medical equipment, it is only to be expected that it would be subjected to the largest amount of complaints, ICIJ says.
"Allegations are not facts and should not be interpreted to suggest that Medtronic violated our legal, ethical or regulatory obligations in any way," Rob Clark, a Medtronic spokesman, said in a statement, adding that any medical product carries a degree of risk.
Medtronic Plc, whose market capitalization amounts to $116 billion, according to Forbes, and whose reported 2017 revenue stood at $29.71 billion, makes devices to help control diabetes, manage chronic pain and alleviate Parkinson's disease, and has invented a wireless pacemaker the size of a vitamin pill.
CORRECTION: The previous version of the article contained a factual mistake stating that one in five of all Medtronic devices was faulty, whereas according to the report, one in five of all adverse events in total was linked to a Medtronic device. The mistake has promptly been corrected.