Adverse Events with Implantable Deep Brain Stimulators - Trends and Insight from the FDA MAUDE Database, 2001 - 2007 (P02.074)

CONCLUSIONS: The frequency of AEs with DBS devices increased dramatically between 2001 and 2007. Within the accepted limitations of a voluntary database, infection and device malfunction are common AEs and often lead to explantation. More serious events such as death or stroke are uncommon. This study includes larger numbers of AEs than prior published reports and reinforces the need for device registries for long-term safety evaluation.Disclosure: Dr. Diaz has nothing to disclose. Dr. McMurtray has nothing to disclose.
Source: Neurology - Category: Neurology Authors: Tags: P02 Movement Disorders: Dystonia Source Type: research