FDA adverse event reports apparently list the deaths as injuries or device malfunctions instead.

Nancy Crotti

Medtech companies have reported more than 4000 patient deaths to FDA as injuries or device malfunctions, according to a joint report by CNBC and NBC New York.

A review of 30,000 adverse event reports going back to 1996 for one type of device, a vagus nerve stimulator, revealed 38 patient deaths reported as injuries or malfunctions, the report said. Five of those patients developed pneumonia and died. The manufacturer, Cyberonics, Inc., said it reported three of the deaths accurately and the other two as human errors.

The networks focused on the case of Shelly Rae Wilhite, 36, an Oklahoma woman with epilepsy who died Sept. 13, 2010, from a heart attack triggered by a suspected seizure.

Wilhite had reported feeling shocks from a Cyberonics vagus nerve stimulator that had been implanted four months earlier to prevent seizures, according to the report.

Cyberonics said it filed a report Sept. 21, 2011 with FDA listing the event as a death and the cause of death as cardiac arrest. FDA lists report from the date received, the referenced report could not immediately be found on the FDA website.

The TV report identified Wilhite's device as the Cyberonics AspireSR 106, but that model was not available in 2010, according to the company. The patient's implant was a Demipulse 103, the company said. Patients are not supposed to feel electric shocks from the stimulators, but other adverse event reports for the Demipulse 103 indicated patients had felt shocks. A federal product liability lawsuit filed by Wilhite's estate against Cyberonics was dismissed without prejudice in 2012.

FDA has received thousands of adverse event reports on vagus nerve stimulators, according to Madris Tomes, a former FDA public health analyst who recently launched York, PA-based Device Events and its Web-based tool that searches medical device postmarket surveillance data.

"There are a lot of reports in there that really made me question the integrity of the reporters," Tomes told the networks.

Medical device manufacturers are required by law to report adverse events to FDA, and are asked to classify each as a death, injury, or device malfunction. Tomes said the agency reviews reported deaths first, but could take weeks or months to review reports listed as injuries or malfunctions. According to a 2010 Inspector General's report, FDA's Manufacturer and User Facility Device Experience (MAUDE) system randomly chooses one of every 10 malfunction reports to review.

FDA said that it does not solely use the event type when deciding the order in which it reviews reports.

Cyberonics, now a subsidiary of LivaNova PLC, conducted its own review of 35,000 adverse event reports it had submitted to FDA, and discovered 108 misclassified reports from 2005 and 2006 that included deaths, injuries, and human and procedural errors. Cyberonics told the  networks that it "never purposely manipulated safety data" and that those errors comprise less than 1% of the company's adverse event reports for those years.

Cyberonics revised its reporting procedures in 2007. "There have not been any significant misclassifications,"  a company spokeswoman told the networks.

"LivaNova chose to provide very detailed factual data to the NBC investigative journalist outlining the stellar track record of VNS and the critical role it plays in improving the lives of patients with epilepsy," the company said in a statement to Qmed. "Regrettably, the journalist chose to profile 1 patient out of more than 90,000 successful implants while virtually ignoring the data in support of VNS implant patient results. Additionally, the story inaccurately associated AspireSR to the patient's death that occurred in 2010. AspireSR was not even available in the US during that time and the patient in this story did not have an AspireSR device.

"It is not LivaNova's place to challenge nor publicly address FDA's MDR adverse event reporting requirements. We are in the business of improving the lives of patients with Epilepsy and AspireSR has been clinically proven to not only improve the quality of patients with epilepsy, but to save lives as well."

Manufacturers must submit a report if they receive or otherwise become aware of information that "reasonably suggests that their device may have caused or contributed to a death or serious injury,"  FDA said in a statement. They must also submit a report if the device has malfunctioned and "would be likely to cause or contribute to a death or serious injury if the malfunction were to recur."

"While reports identifying death as the event type are one type of report that receives high priority review from FDA, we simultaneously look for reports that describe similar circumstances and related events through all report types, including those that involve serious injuries or malfunctions of the device," the statement continued. "We do not rely solely on event coding by manufacturers to prioritize this review. We prioritize based on all available information."

More than 50,000 serious adverse events are reported annually, including over 3,000 deaths, according to a 2015 FDA report. Medtech safety issues often go unidentified until multiple patients get hurt or die, such as during the superbug outbreaks linked to dirty Olympus duodenoscopes. FDA didn't warn hospitals about that problem until the LA Times reported that duodenoscope-related infections killed three patients at a UCLA hospital.

The agency is working on a new national evaluation system that would link and synthesize data from different sources across the medical device lifecycle, including clinical registries, electronic health records, medical billing claims, data transmitted from devices, and other digital sources.

Nancy Crotti is a contributor to Qmed.

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