Safety Advisories and Adverse Event Reports

As an additional step, the committee investigated FDA safety advisories and similar information to determine whether any appeared to have been prompted by adverse event reports associated with children’s activity levels or growth and development on device longevity or performance. The committee found some advisories based at least in part on adverse event reports involving children, but none of the reports obviously involved problems arising from children’s activity levels or growth and development. For example, a public health notification on the risk of bacterial meningitis in children with cochlear implants did not cite developmental considerations explicitly. It stated, however, that it focused on young children “because they account for the majority of known meningitis cases and represent the population that will receive most cochlear implants in the future” (Pressly, 2003, p. 2). The study that investigated the meningitis risk and led to the notification is discussed further below.

Searches of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database yielded some examples of adverse event reports that might be attributed to children’s activities. For example, use of “basketball” as a search term produced a few potentially relevant reports of incidents involving people playing basketball, although the public database available to the committee did not allow determination of whether these incidents involved children.

The committee concluded that a more systematic search of the MAUDE database was not feasible because the array of possible “active-lifestyle-related” events and possible narrative descriptions of such events is very large, and no recognized nomenclature exists to characterize them. In any case, although FDA has evaluation codes for manufacturers to characterize their evaluation of an adverse event, the agency offers only four very general codes related to use or behavioral factors, for example, “user error caused event” (FDA, 2001j, p. 4). Other patient and device codes are also not specific for lifestyle-related events. In sum, if the narrative for an adverse event report said something like “problems with implant functioning arose after the child jumped off the sofa and bumped her head,” no existing code or feasible search strategy would identify this incident as related to children’s active lifestyle.

Similar difficulties limit the feasibility and value of searching the database for reports that might identify adverse events related to growth and development. For example, reports of a device migration (for which several codes exists) may be related to many factors not related to growth and development. (One device code, 1272, indicates that a device will not support growth [FDA, 2001b].) The committee concluded that further examination of adverse event reports would not be useful in assessing whether

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