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

Model Number 8637

Device Problems Improper or Incorrect Procedure or Method (2017); Aspiration Issue (2883)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Seizures, Grand-Mal (2168); Complaint, Ill-Defined (2331)

Event Date 11/18/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: neu_unknown_cath, lot# unknown, product type: catheter.Goodman.E.R, malik, t., sudhakaran, s.Intrathecal pump failure leading to intubation and icu admission: a case report.Asra: 16th annual pain medicine meeting.2017-nov-18.Http://epostersonline.Com/asrafall17/node/711?view=true.Please note that this date is based off of the date of presentation of the poster as the event date was not provided.If information is provided in the future, a supplemental report will be issued.- (b)(4).

Event Description

Summary: a (b)(6) year-old (b)(6) female with multiple sclerosis complicated by spasticity and chronic back pain who had an intrathecal pump placed for her chronic pain management.Reported event: information was received regarding a (b)(6) year-old female patient who was receiving baclofen (225 mcg/day), fentanyl (150 mcg/day), and bupivacaine (5 mg/day) via an intrathecal pump for chronic pain management.It was reported an intrathecal pump failure leading to intubation and icu admission occurred.The cause was due to a baclofen overdose after a catheter dye study.The cerebrospinal fluid (csf) flow from the catheter access port (cap) was poor, but contrast dye was injected through the cap, pushing residual medication in the catheter into the csf.The event was also reported as follows.The patient was frequently seen in the pain clinic over the course of one year where her baclofen requirements increased from 115 mcg/day to 300 mcg/day.Due to the increasing requirements, a dye study under fluoroscopy was undertaken to interrogate the integrity of the patient's pump system.The cap was aspirated with slow csf return.Contrast dye was injected into the port, which revealed patency of the catheter to the intrathecal space, but with poor intrathecal spread.Bupivacaine was removed from the intrathecal regimen and fentanyl was decreased to 100 mcg/day; baclofen was increased to 300 mcg/day.The catheter was primed from the pump with 0.25 ml of a new solution containing 236.85 mcg/ml of fentanyl and 710 mcg/ml of baclofen.The patient was observed for 4 hours prior to discharge.Approximately 13 hours after the priming bolus, the patient became altered and presented to the emergency department (ed).In the ed, the patient experienced a tonic-clonic seizure lasting two minutes, and was bradycardic with a heart rate in the 30's-40's.The patient was subsequently intubated for airway protection and was admitted to the neuro icu.Over the course of the admission, the patient's baclofen and fentanyl doses were decreased.On day three of admission, the patient was scheduled to undergo an mri of the brain and spine to evaluate for new ms lesions and evidence of a catheter tip granuloma.However, it was canceled due to persistent hypotension and bradycardia.The patient was started on a norepinephrine drip.The patient was extubated on day three of admission.The fentanyl dose was lowered to 45 mcg/day and baclofen to 135 mcg/day.An mri revealed stable white matter lesions and no evidence of a catheter tip granuloma.The patient was ultimately discharged home on day four of admission, and was scheduled to follow-up with neurosurgery for a surgical exploration of her it pump system.During open exploration of the intrathecal pump and catheter, the cap was accessed and aspiration revealed free flowing csf.Omnipaque was then injected, revealing an intact catheter with spread of dye into the intrathecal space confirming an intact system.The patient's medical history included multiple sclerosis complicated by spasticity and chronic back pain, morbid obesity (bmi of 41.2), migraines, obsessive compulsive disorder (ocd), pulmonary embolism, and a single level lumbar fusion.The patient's concomitant medications included acetaminophen 325mg q4hr prn, albuterol inhaler q4hr prn, alprazolam 2mg tid prn, baclofen 40mg tid po, biscodyl rectal suppository, famotidine 20mg bid, fluticasone nasal spray, fondaparinux 10mg subq injection daily, gabapentin 800mg tid, hydrocodone-acetaminophen 5-325mg 1-2 tabs q6hr prn, melatonin 6mg qhs, ondansetron 4mg q6hr prn, sertraline 150mg daily, and tizanidine 2mg bid and 4mg qhs.

• Brand Name: SYNCHROMED II
• 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: 7072816
• MDR Text Key: 93419763
• Report Number: 3007566237-2017-05015
• Device Sequence Number: 1
• 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,study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2017
• Initial Date FDA Received: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR