Classifying Device-Related Complications Associated With Intrathecal Baclofen Pumps: A MAUDE Study.

BACKGROUND: Intrathecal baclofen (ITB) is an effective treatment for spasticity, and therapeutic levels may be optimized using surgically implanted pumps. Though these devices are effective, complications can pose significant challenges to patients, decreasing the therapeutic effect and potentially requiring reoperation. As such, it is critical that complications associated with ITB be effectively characterized. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database for cases reported during the past 3 years documenting adverse events specifically related to ITB pumps. We identified 1935 adverse events that were individually analyzed and categorized by type of complication. RESULTS: Out of the 1935 unique adverse events identified from the MAUDE database, 25.7% were device-related complications (n = 497). Of those, 50.3% were catheter-specific (n = 250), 21.3% (n = 106) were pump-specific, and 28.3% (n = 141) were included, more generally, in catheter or device erosion. CONCLUSIONS: The MAUDE database may be a useful resource for evaluating ITB pump complications across a larger data set. By characterizing the complications and providing values for their total occurrences, patients and physicians may have more realistic expectations for the outcomes and morbidity of this device.