title: Injury and Liability Associated with Implantable Devices for Chronic Pain.
abstract: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices.
  
  
  
  After 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.
  
  
  
  The 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).
  
  
  
  Half 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.
authors.affiliation: 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.).
authors.forename: Dermot R
authors.initials: DR
authors.lastname: Fitzgibbon
authors.forename: Linda S
authors.initials: LS
authors.lastname: Stephens
authors.forename: Karen L
authors.initials: KL
authors.lastname: Posner
authors.forename: Edward
authors.initials: E
authors.lastname: Michna
authors.forename: James P
authors.initials: JP
authors.lastname: Rathmell
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Pollak
authors.forename: Karen B
authors.initials: KB
authors.lastname: Domino
mesh_terms: D059350:Chronic Pain / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000009:adverse effects* / Q000191:economics / Q000295:instrumentation*; D005260:Female; D006801:Humans; D015918:Infusion Pumps, Implantable / Q000009:adverse effects* / Q000191:economics / Q000706:statistics & numerical data; D007345:Insurance Claim Review / Q000191:economics / Q000706:statistics & numerical data; D007351:Insurance, Liability / Q000191:economics / Q000706:statistics & numerical data*; D008297:Male; D008318:Malpractice / Q000191:economics / Q000706:statistics & numerical data*; D008875:Middle Aged