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

Model Number NEU_UNKNOWN_PUMP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Bradycardia (1751); Dyspnea (1816); Edema (1820); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Hypothermia (1915); Hypoventilation (1916); Muscle Weakness (1967); Overdose (1988); Loss of Range of Motion (2032); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Loss of consciousness (2418); Respiratory Acidosis (2482); Decreased Respiratory Rate (2485); Cognitive Changes (2551); Confusion/ Disorientation (2553); Lethargy (2560); No Code Available (3191)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth.This value is the age of the unnamed male patient.The age of the unnamed female patient is (b)(6).Sex.This value reflects the gender of (b)(6) patient.The gender of (b)(6) patient is female.Date of event.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.References the main component of the system.Other relevant device(s) are: product id: neu_unknown_pump, serial/lot #: unknown.Per fda draft guidance july 9 2013 these events are reported on one mdr due to no patient identifier citation: ryan s, dudley n, green m, et al.Altered mental status at high altitude.Pediatrics.2018;142(2):e20173973.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary/abstract: intrathecal baclofen pumps are commonly used in pediatric patients with spastic cerebral palsy.Baclofen binds to g-aminobutyric acid receptors to inhibit both monosynaptic and polysynaptic reflexes at the spinal cord level.The blockade stops the release of excitatory transmitters and thereby decreases muscle contraction.It is commonly used for lower limb spasticity and has been shown to improve postural ability and functional status.The us food and drug administration has approved baclofen for the treatment of spasticity of cerebral or spinal origin in adult and pediatric patients 4 years or older.Various complications of baclofen pumps are described in the literature.Immediately after surgery, problems from infection can arise and range from superficial skin infections to meningitis and bacteremia.Another early complication includes cerebrospinal fluid leak that can be observed by notable swelling beneath the lumbar incision.Additional problems that arise later are usually from the mechanics of the pump and catheter.Pump-related complications include failure, migration, and flipping.Catheter-related complications include disconnection, occlusion, fracture, or kink.Most of these complications typically lead to baclofen withdrawal, although there are a few case reports of overdose due to mechanical causes.Here we describe 2 cases of individuals experiencing complications of excessive baclofen exposure after significant changes in the atmospheric pressure due to travel involving ambient altitude change.These cases reflect the need to discuss this potential complication with families and patients with baclofen pumps before travel to high elevations.Reported events: here we review 2 cases of adolescent patients with overinfusion of baclofen via itb pump after travel to high altitude resulting in altered mental status, hypotonia, hypoventilation, and vomiting.A 15 year old with a history of mild right-sided cp due to perinatal ischemic injury presented via air transport to our tertiary care pediatric emergency department (ed) with altered mental status.For the past 2 days, he was on a backpacking trip in the nearby mountains, above an elevation of 9000 ft.Approximately 4 to 5 days before presentation, he traveled from sea level to an area at 4500 ft altitude to acclimate.During the second day of his visit, before beginning his backpacking and camping trip, he took a day hike to >9000 ft.The day before his presentation at our facility,he hiked 6 miles at 9500 ft and was in his usual state of health that night before going to sleep in the tent.On the morning of presentation, his family member checked on him at 10 am for breakfast, but he was somnolent and mumbling.His family assumed he was tired, so they allowed him to sleep for another 2 hours.At approximately noon they tried to wake him, but he was difficult to arouse and responded to a sternal rub with only limited movement of his extremities.His family initiated rescue via a flight crew, and he was given 1 l normal saline and placed on a non-rebreather mask for shallow breathing.There was no reported hypoxemia, new exposures, recent illness, or trauma.His only medication was baclofen through a pump, which had been increased by 10%, up to 599 ¿g per day.It was increased the week before in anticipation of the backpacking trip to allow for increased mobility.In the ed, he was somnolent, hypothermic to 34.5°c, hypotonic, and with mydriasis to 5 to 6 mm.He had a glasgow coma scale (gcs) of 9 (eye response 2, verbal response 2, and motor response 5).His respiratory effort was shallow, his heart rate was 50 with some variability, and his blood pressure was 103/52.Our differential diagnosis included high-altitude cerebral edema, trauma, ingestion, electrolyte abnormality, infection, or baclofen overdose.He was placed on nasal cannula oxygen while a workup was initiated.His laboratory results revealed a normal creatinine kinase, negative urine and serum drug screen, normal complete blood count, slight respiratory acidosis with a ph of 7.29 and pco2 of 48, normal electrolytes, and normal glucose.He was given maintenance intravenous fluids of normal saline at a rate of 100 ml/hour.A head computed tomography scan revealed chronic changes of slight left-sided asymmetry adjacent to parenchymal brain loss without hydrocephalus, and a small amount of air was noted within the suprasellar cistern, which likely reflected his recent access to the baclofen pump when they increased the dose.He was admitted to the picu after a baclofen pump interrogation by the physical medicine and rehabilitation consultant.There were no signs of baclofen pump malfunction.However, his baclofen dose was reduced by 10%, 540 ¿g/day, which was the dose he was on before leaving his home at sea level.On admission to the icu, his mental status improved with a gcs of 14.With improvement in his mental status, he no longer required oxygen support.He was transferred to the medical floor team several hours later with continued improvement and was discharged the next day.A (b)(6) with spastic cp presented to our tertiary care pediatric ed with altered mental status and vomiting via ambulance.She was in her usual state of health until that morning when she started having multiple episodes of nonbloody, nonbilious emesis.She traveled from sea level to 7000 ft 9 days before presentation.She had been participating in outdoor activities including hiking above an elevation of 8000 ft and horseback riding.She had progressive somnolence throughout the day and was found in her bedroom unresponsive.She did not have recent illness, medication changes, trauma, or new exposures.In the ambulance, her vital signs remained stable and she did not require oxygen support.Her last change in baclofen dose occurred 4 years ago.Her baseline rate was 419 g/day and she took no other medications.On arrival to the ed, she was hypoventilating with a rate of 10, hypothermic to 35.4°c, hypotonic, and aroused to voice.Her gcs was 14 on arrival, with eye opening to command, clear and appropriate speech, and movement spontaneously of all extremities.Her laboratory results revealed normal electrolytes, normal glucose, and normal complete blood count.Physical medicine and rehabilitation professionals were consulted, and the decision was made to admit her to the 24-hour observation unit without changes to her baclofen pump.Over the course of 6 hours, she returned completely to baseline, and the family drove home the next day.Our pediatric ed is located at 4300 ft in elevation, which may have played a factor in the patients¿ improvement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7759042
• MDR Text Key: 116394361
• Report Number: 3007566237-2018-02330
• Device Sequence Number: 0
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 15 YR