The device maker was unaware for more than three months that a patient who underwent spinal surgery with one of its products had died, and will now report the episode to the FDA, The Wall Street Journal reports.

In August, Medtronic reported to the FDA that the patient, Shirley Nisbet, was having trouble breathing and fell into a coma four days after a spinal-fusion surgery that used a Medtronic’s Infuse BoneGraft implant for promoting bone growth (see picture). The device maker tells the paper that learned only last week that Nisbet had died, citing a lawsuit filed by her family.

The FDA requires adverse events to be reported as companies learn about them, whether or not they believe the product was the cause. Initial reports must also be followed up and info that changes the facts of a case must be reported to the agency. Medtronic and the hospital where the surgery was performed, a Kaiser Permanente facility in California, declined to discuss whether the company sought updates on Nisbet after reporting she was in a coma, the paper writes. She died on August 30, two days after the date of Medtronic’s initial report.

The episode comes amid mounting controversy over Medtronic and Infuse promotional practices. In July, an FDA safety alert linked the use of Infuse in the neck area with potentially life-threatening complications. Although Infuse isn’t approved by the FDA for that part of the body, doctors are free to use the device for such off-label purposes. Infuse’s off-label use is the subject of a Justice Department investigation (back story) and a separate US Senate probe. Meanwhile, whistleblower lawsuits have been filed over alleged off-label promotion, including one last week (see here and here).

The FDA recommends that a manufacturer should make at least three attempts to retrieve additional info about a reported event, with at least one attempt in writing, an agency spokeswoman tells the Journal, although she declined to discuss Medtronic’s reporting in this case, as did the company.

Last year, the FDA issued a warning letter to Medtronic, saying it had failed to properly report adverse events related to devices in its neuromodulation business. The company said the issues raised in the letter have been resolved. Jim Anderson, a spokesman for the Kaiser hospital where Nisbet died, tells the Journal the facility didn’t report the death to Medtronic or the FDA “because we do not consider the product to be the direct cause of death.”

Nisbet’s family filed a lawsuit in federal court in Los Angeles earlier this month alleging that the spine surgery in her neck area involved an unapproved, or off-label, use of Medtronic’s Infuse Bone Graft product, the Journal writes, adding that, according to the suit, Nisbet went into respiratory arrest following surgery, fell into a vegetative state, and was “kept alive by artificial means” until she died.

Medtronic has maintained Infuse is a safe product and that any complications associated with its use represent a tiny percentage of cases.