The Sprint Fidelis is an implantable cardioverter-defibrillator created to shock the heart in order to regulate its rhythm.
According to CNN, the device was recalled Oct. 15, 2007 for shocking at inappropriate times and being a likely contributor in 5 patient deaths, later changed to 13.
At the time of its recall, the product had already been implanted in the heart tissue of 268,000 patients.
Medtronic advised against having the lead surgically removed to prevent major complications, including death.
Since the product’s recall, over 50,000 reports have been made about the product malfunctioning and causing injury.
Many of the reports—over 35,000 cases—involved more than one issue with the device. Issues included 2,900 incidents of inappropriate shocks and 22,000 instances of lead fractures.
Despite these serious statistics, the public was kept unaware of the product’s high likelihood to malfunction due to an exemption the FDA issued to Medtronic in 2008.
For 20 years, the FDA has been granting various devices certain exemptions from reporting to MAUDE, their public-facing database, according to KHN.
One of those exemptions was granted to the Sprint Fidelis on May 8, 2008. According to CNN, this “remedial action” exemption allowed new reports about the product’s malfunctioning or causing injury to be hidden from the public.
The reasons provided by the FDA to justify this action were that the manufacturer had already taken all possible steps to stop the problems and that the additional data would not provide any new significance.
However, hiding this information from the public caused many people who already had the defibrillator inside their bodies to be unaware of its high likelihood to malfunction and cause injury or death.
Information provided by CNN:
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