investigate reports that do not involve deaths and other high-profile events.

It is worth reiterating that in addition to adverse event reports, FDA may learn of potential problems with a marketed device or its use in other ways, including during inspections of facilities and as part of ongoing manufacturer efforts to refine and improve a product. Problems may also be detected during postmarket clinical studies sponsored by manufacturers, the National Institutes of Health (NIH), or others. Other avenues of problem identification include published case reports of unusual or unexpected problems, presentations at medical conferences, or informal conversations associated with such meetings. Such conversations were an early indicator of a possible link between cases of meningitis and cochlear implants (see Appendix F).


“I never really thought about reporting that [problem] in particular…. There are just millions and millions of things that can go wrong.”

Melisande Statz-Hill, parent, 2004

This mother of a young child cared for at home with multiple medical devices was making two points. First, it did not occur to her to report (even to the home health agency) a problem that seemed to involve error in the use of a device—in this case overtightening by a nurse of ties for a tracheostomy tube—rather than a malfunction of the device itself. The second point was that the opportunities for something to go wrong—even for a family with private-duty nursing support and a home health company that specialized in pediatric patients—seemed endless.

To illustrate the many kinds of adverse device events (and device malfunctions and close calls) and the challenges of analyzing such events, the committee developed several vignettes or synthetic case histories. They are intended to convey both the diversity of device events and the interplay of variables associated with events and their aftermath. These variables include the complexity of the device and its management, the setting of care and its characteristics, the characteristics of the patient (e.g., developmental stage), the circumstances of the family (e.g., understanding of how to operate a device correctly at home), the opportunities for (or impediments to) reporting the event, and the resources brought to bear on understanding the event. The examples do not attempt to represent proportionately the distribution of reported (much less actual) adverse events by type of device, problem, or reported consequences.

Each story below is simplified to highlight issues of interest. Some describe situations that are reasonably common and even accepted as “nor-

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