SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Dermot R. Fitzgibbon
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.