• Anesthesiology · Jun 2016

    Injury and Liability Associated with Implantable Devices for Chronic Pain.

    • Dermot R Fitzgibbon, Linda S Stephens, Karen L Posner, Edward Michna, James P Rathmell, Kelly A Pollak, and Karen B Domino.
    • From the Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington (D.R.F., L.S.S., K.L.P., K.A.P., K.B.D.); Pain Management Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (E.M.); and Department of Anesthesia, Critical Care, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (J.P.R.).
    • Anesthesiology. 2016 Jun 1; 124 (6): 1384-93.

    BackgroundDue to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices.MethodsAfter institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues.ResultsThe most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001).ConclusionsHalf of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

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