The FDA letter raised doubts if St Jude had corrected the problem, “The adequacy of your firm’s response cannot be determined at this time. Your firm provided a summary of, and implementation dates for, several corrections, corrective actions, and systemic corrective actions. However, in your firm’s response, you failed to provide evidence of implementation for your firm’s corrections, corrective actions, and systemic corrective actions.”
There were to 841 documented cases of early battery depletion that resulted in two deaths, according to all reports.
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