Abstract
STUDY DESIGN: Retrospective cohort study. INTRODUCTION: Malpractice claims analysis is performed by several specialties to improve quality of patient care and to identify areas where physicians can improve their practice to mitigate the incidence of committing malpractice. The Food and Drug Administration has flagged over 80,000 injuries caused by spinal cord stimulator (SCS), making them the 3rd most flagged medical device. This study analyzed malpractice claims due to SCS by querying two legal databases widely used in medicolegal research. METHODS: Westlaw Edge and VerdictSearch were queried for malpractice cases filed between the years 2000 and 2022 using the keywords "spinal cord stimulator." Case inclusion criteria was defined as a plaintiff's basis of litigation resting on a claim of medical malpractice due to SCS. Additional data collected included date of case hearing, plaintiff sex and age, defendant specialty, verdict ruling, location of the filed claim, payment or settlement amount, and sustained injuries. RESULT: Of the 1773 reviewed cases, 45 cases were included and categorized as battery or implantable pulse generator malfunction (35.56 %), lead complications (28.89 %), surgical complications (20.00 %), and miscellaneous (15.56 %). Four (8.89 %) cases resulted in settlement, 11 (24.44 %) in a plaintiff verdict, and 30 (68.00 %) resulted in a defendant verdict. Claims filed due to infection related to SCS were more likely to result in a defendant verdict (p = .047), whereas claims filed due to neurological deficit were more likely to result in a plaintiff verdict (p = .020). The average settlement amount for the 4 cases is $1,975,309.61. CONCLUSION: Our findings suggest obtaining adequate neuroimaging preoperatively with MRIs, disclosing neurological risks specifically paralysis on informed consent, and evaluating radiography intraoperative and postoperatively with anterior-posterior (AP) and lateral x-ray films to ensure proper SCS placement are practices that may mitigate malpractice due to SCS. Battery defects and lead complications were the most common grounds for SCS-related malpractice claims.