Shortly after the recall, the FDA and Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — now totaling 50,000 — shielded from public scrutiny. The FDA has allowed device makers to file 1.1 million reports of injuries or malfunctions to a little-known internal FDA database since 2016, a recent Kaiser Health News investigation has found, spurring top FDA officials to pledge to open those records within weeks and shut down the “alternative summary reporting” program. For the past two decades, the agency has granted various devices different types of so-called exemptions from reporting to...