Georgia case library

Emory Rehabilitation Hospital complaint alleges baclofen pump programming overdose

The complaint alleges that a patient with a history of traumatic brain injury presented to an Emory facility for a routine intrathecal baclofen pump refill, and that a Medtronic SynchroMed pump was programmed to deliver 400 micrograms per day instead of the intended 200 micrograms. The alleged programming error caused baclofen toxicity, toxic encephalopathy, ICU admission, seizure activity, permanent seizure disorder, and reduced motor function.

System
Emory Healthcare
Facility
Emory Rehabilitation Hospital
Providers involved
David T. Burke, M.D. / Emory Rehabilitation Hospital / Emory Brain Health Center
Pattern
Alleged medication programming error during intrathecal baclofen pump refill
Harm
Alleged baclofen toxicity, toxic encephalopathy, permanent seizure disorder, and reduced motor function

Overview

This page concerns a public complaint alleging that an implanted baclofen pump was incorrectly programmed during a refill at an Emory Healthcare facility, causing baclofen toxicity and neurological injury.

Chronology

The complaint alleges as follows:

  1. The patient suffered a traumatic brain injury in a motorcycle accident in March 2019.
  2. A SynchroMed pump was implanted in August 2020 to manage chronic spasticity.
  3. The patient presented to the Emory Brain Health Center for a scheduled pump refill on October 24, 2023.
  4. The pump was incorrectly programmed to 400 micrograms per day instead of 200 micrograms per day.
  5. The patient was found unresponsive at home the next day and was transported by EMS to the Emory University Hospital ICU.
  6. The patient suffered a seizure, and neurology confirmed that the pump was set at double the intended dose.
  7. The patient was discharged with a principal diagnosis of baclofen toxicity.

Alleged failures

The complaint alleges the following failures:

  • Providers failed to conduct a required time-out verification before the pump-refill procedure.
  • The physician failed to ensure that the pump was refilled and programmed with the correct daily dose.
  • Providers failed to properly document medication and prescription data.
  • Providers failed to provide timely post-procedure monitoring or guidance after the alleged programming error.
  • Corporate entities failed to properly credential and manage the healthcare providers involved.

Entities and tags

Emory Rehabilitation HospitalEmory Brain Health CenterDavid T. Burke, M.D.Medtronic SynchroMed pumpBaclofen pumpIntrathecal pumpBaclofen toxicityToxic encephalopathySeizure disorderMedication errorEquipment failureFailure to monitorDocumentation failuresPhysical medicine and rehabilitationNeurologyMedication safetyDevice programming