The FDA slapped Medtronic ($MDT) with a warning letter over a faulty implantable drug infusion pump that appears susceptible to corrosion, a fatal flaw that could injure patients.
While regulators noted that the company responded to the concerns and had taken some action to address the problem, the FDA said the responses to various quality system manufacturing violations at the division's Minnesota facility fell short. Medtronic was required to respond to the July 17 dated letter within 15 days of receipt. Regulators also said they wouldn't approve any approval submissions in the category until the matter is solved.
Medtronic could not be reached for comment in time for deadline. But Reuters noted that Medtronic disclosed during its fiscal 2013 first quarter earnings call that the warning would not adversely affect earnings.
In an unusual twist, the letter addressed Medtronic CEO Omar Ishrak directly, rather than the head of Medtronic Neuromodulation, the division that manufactures the product. According to the letter, concerns over corrosion regarding Medtronic's SynchroMed II pump go back to 2007, when the issue was first raised that motor corrosion could cause the device to stall, damage the gear teeth and impair the drug delivery process.
Medtronic created a corrosion task force and planned an in depth review of product complaints. But the FDA faulted the company, in part, for not clearly explaining what it is doing to prevent future problems, the letter explains. Regulators also want to plan a follow-up inspection, to evaluate whether Medtronic has pursued enough solutions to fix the issue.
At the same time, the FDA also took issue with the company not creating a procedure in the wake of the initial problem with SynchroMed II to more better receive, review and evaluate complaints regarding the device. Those complaints have ranged from stalled motors to weird vibrations.
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