• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number NEU_UNKNOWN_PUMP
Device Problems Improper or Incorrect Procedure or Method (2017); Device Ingredient or Reagent Problem (2910)
Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Coma (2417); Loss of consciousness (2418); Decreased Respiratory Rate (2485); Cognitive Changes (2551); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
Citation: pearson rp, hoang lk, roufail j, muhonen mg, galion aw. Baclofen toxicity mimicking brain death: a case report of a pediatric patient. Pediatr emerg care. 2021;37(3):e141-e146. 10. 1097/pec. 0000000000002361 b. 3. Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Citation: pearson rp, hoang lk, roufail j, muhonen mg, galion aw. Baclofen toxicity mimicking brain death: a case report of a pediatric patient. Pediatr emerg care. 2021;37(3):e141-e146. 10. 1097/pec. 0000000000002361 summary: background: baclofen is commonly used in both pediatric and adult patients to treat spasticity secondary to spinal cord and cerebral pathology. A broad range of symptoms and severity of baclofen toxicity have been described. However, to our knowledge, there are no reports to date of baclofen toxicity mimicking brain death in pediatric patients objectives: we reviewed the presentation, clinical course, diagnostic studies including imaging and electroencephalography, and outcome of a patient with transient coma and loss of brainstem reflexes mimickingbrain death secondary to baclofen toxicity materials and methods: during a baclofen pump refill, a (b)(6) year-old boy with cerebral palsy had inadvertent injection of 12,000 ¿g of baclofen into the pocket around his pump. Within an hour, he presented with acute altered mental status that rapidly progressed to a comatose state with absent brainstem reflexes. Results: after appropriate management, the patient returned to his neurological baseline by hospital day 3. Discussion: we reviewed the literature for varying presentations of baclofen toxicity and associated electroencephalography findings, mechanism of overdose, and different management options. In this case, the mechanism of baclofen toxicity was suspected to be secondary to extravasation from the pump pocket and subsequent systemic absorption. Conclusions: patients with baclofen toxicity may have a dramatic presentation and an initial examination mimicking brain death. Given its rarity,this clinical entity may not be readily recognized, and there is potential for misinterpretation of diagnosis and prognosis. It is important for physicians to be familiar with this clinical scenario to avoid false declaration of brain death. Reported events: a (b)(6) year-old boy with history of ex-26 week prematurity, spastic quadriplegic cerebral palsy, and epilepsy was admitted for altered mental status after a refill of his it baclofen pump at a routine neurosurgery clinic visit. The baclofen pump was placed at age 5 years. His last seizure was 4 years ago, and he had been tapered off of levetiracetam 3 to 4 months before this admission. On the day of admission, the patient had been in his usual state of health when he was seen at neurosurgery clinic for a pump refill. The pump was interrogated and read a basal rate of 28 ¿g per hour with a 75-¿g bolus at 8:00 pm and total daily dose of 746. 1 ¿g. The pump was mapped out using the medtronic template. The patient was prepared with chloraprep. A 22-gauge needle was inserted into the baclofen pocket area and into the baclofen pump. There was no immediate drawback of medication. The needle was manipulated, and serosanguinous fluid was drawn back. It was felt that the needle went into the baclofen pump, and 5 ml of the medication was aspirated from the reservoir; however, it was slightly tinged pink. The tubing was clamped, and a syringe containing 20/2000 gablofen medication was used. Ten milliliters of the stated medication was placed into the pump. The area was once again prepared with chloraprep, and a 22-gauge huber needle was used to access the pump. There was drawback of serosanguinousfluid, and then clear fluid. A new syringe containing the medication was attached to the tubing, and medication was used to fill the pump to a total of 20 ml. The syringe and needle were removed, and the pump was then reprogrammed to deliver 10% increase in flex dosing (820 ¿g/d). For extra precaution, ultrasound was used to visualize the baclofen pump and pocket to confirm that there was no fluid within the pocket. No excess fluid was noted on the ultrasound scan. Within 5 minutes after the refill, the patient's father reported that the patient seemed different while in the elevator as they were leaving the clinic; he was more talkative as if he were high. In the parking lot, he became quieter, and when dad picked him up, he was completely limp. They returned to the neurosurgery clinic, where a needle was inserted into the baclofen pocket area and withdrew serosanguinous fluid from the baclofen pocket, as well as possible medication. The baclofen pump was interrogated and reprogrammed to deliver the minimal rate of 12. 5 ¿g per day. Despite this, the patient became less responsive with sternal rub. Emergency medical service was called, and he was taken to the emergency department. Upon arrival to the emergency department, vital signs were rectal temperature 36. 1¿c, blood pressure 98/56 mm hg, pulse 81 beats/min, decreased respiratory effort with respiratory rate at 7 to 12 breaths/min, saturating 100% on room air. He was not responsive; pupils were nonreactive at 2 mm, and glasgow coma scale (gcs) was 3. Venous blood gas measured ph 7. 157, pco2 73. 6, hco3 25. 5, and base excess -4. 7. Complete blood cell, comprehensive metabolic panel ammonia, and lactate were normal. Electrocardiogram showed normal sinus rhythm. He was intubated for airway protection. Neurosurgery accessed the side port of the baclofen pump in the emergency department and removed 5 ml of cerebrospinal fluid (csf) as well as possible baclofen medication from within the it space. The baclofen pump reservoir was accessed and all remaining medication was removed, and then 10 ml of sterile normal saline was injected. The patient was admitted to the pediatric intensive care unit for close monitoring. In the early morning of hospital day 0, approximately 9 hours after the pump refill, the patient had 3 seizures (described as bilateral upper and lower extremity shaking and eyes rolling around, duration ranging from 15 seconds to 1. 5 minutes). He was given lorazepam 0. 1 mg/kg and fosphenytoin load 20 mg/kg. He was then noted to have fixed and dilated pupils. Stat head computed tomography was negative for acute intracranial abnormalities. The neurology team was consulted. On the neurologist's initial examination, he was comatose and intubated (not on any sedation). His right pupil was oblong (may have been chronic) and nonreactive; the left pupil was 4 mm and nonreactive. He had no corneal reflexes and no gag reflex. Tone was flaccid throughout; he had no spontaneous movements and no response to noxious stimuli. He was areflexic throughout, and extensor responses were mute bilaterally. Long-term video electroencephalography (eeg) was started on hospital day 0 at approximately 15 hours after onset of altered mental status. In the beginning of the recording, a burst suppression pattern was noted, with bursts of high amplitude, sharply contoured theta and delta activity with occasional diffuse spike and slow wave discharges, alternating with periods of background attenuation lasting up to 10 seconds at a time (fig. 1). Over time, the interburst interval shortened down to 2 to 3 seconds during the first 12 hours of recording and slowly progressed to continuous diffuse polymorphic delta slowing in 1- to 2-hz frequency toward the end of the recording period (fig. 2). Superimposed beta activity with anterior lead predominance was seen. There were no sleep architecture or arousal patterns noted throughout the study. No background reactivity was observed when painful stimuli were applied. No posterior dominant rhythm was seen. On hospital day 1, pupils were sluggish but reactive; corneal and gag reflexes were present, and there was some withdrawal to noxious stimuli. On hospital day 2, the patient was noted to have some spontaneous movements. Magnetic resonance imaging of the brain with and without contrast was obtained and demonstrated no acute intracranial findings. He was extubated later that day. On hospital day 3, he returned to neurologic baseline, and the baclofen pump was refilled, with one-half of priming bolus given to avoid risk of overdose, and a lower daily dose of baclofen was started (500 ¿g daily vs previous dose of 800 ¿g daily). See attached literature article.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIMPLANTABLE DRUG INFUSION PUMP
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12072380
MDR Text Key263133479
Report Number2182207-2021-01128
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 06/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_UNKNOWN_PUMP
Device Catalogue NumberNEU_UNKNOWN_PUMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/26/2021 Patient Sequence Number: 1
-
-