MAUDE Adverse Event Report: RICE CREEK MFG SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Pumping Stopped (1503); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Pain (1994); Scar Tissue (2060)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Citation: warner, l., branstad, a., hunter guevara, l.Et al.Malfunctioning sufentanil intrathecal pain pump: a case report.J med case reports 14, 1 (2020).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.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: warner, l., branstad, a., hunter guevara, l.Et al.Malfunctioning sufentanil intrathecal pain pump: a case report.J med case reports 14, 1 (2020).Summary: sufentanil is a potent opioid uncommonly used to manage pain and is rarely administered via an intrathecal pain pump system.This case illustrates the use of intrathecal sufentanil in a (b)(6) caucasian man for the management of chronic pain; however, the intrathecal drug delivery system experienced a malfunction which led to 1/100th output of the correct dosage.Interesting aspects of this case report include the uncommon choice of sufentanil use for an intrathecal drug delivery system, as well as the unusual pharmacokinetics of this drug.Specifically, this patient did not experience the major withdrawal that would be expected given significant under dosing of opioid, and this may be explained by the lipophilicity and context-sensitive half-times of sufentanil.Because of the absence of a clinically significant withdrawal in this case report, clinicians must be aware of relevant pharmacokinetic properties and unusual intrathecal drug delivery system technologies that influence a patient¿s response when device malfunction occurs.Reported event: our patient was a (b)(6) caucasian man, with a body mass index (bmi) of 31 and a past medication history significant for chronic back, neck, and leg pain since early 2000 after he sustained a traumatic fall at work.Other medical co-morbidities included degenerative joint disease, bursitis, depression, type ii diabetes mellitus, hypothyroidism, testicular hypofunction, and hyperlipidemia.His family history and social history were noncontributory.The severity of his work injury ultimately required a cervical and lumbar fusion.The majority of his pain was localized to his low back and posterior legs without symptoms of crps.Three different types of pain were described: a constant and dull back pain, electric shocking pain in his legs, and numbness and tingling in his feet.After failing conservative opioid analgesic management, an intrathecal pain pump, medtronic synchromed iib, was placed at a non-mayo facility in 2006 (10 years prior to malfunction).Records were not available detailing the reason for using sufentanil.After placement, his pain was significantly improved with an average daily numerical rating scale of 2¿3/10.His pump was originally programmed with sufentanil (50 mcg/ml) with a daily dose of 38.307 mcg/day.Home medications included hydrocodone-acetaminophen 5 mg-325 mg (two tablets in the morning and two tablets in the evening) along with gabapentin 300 mg three times a day for neuropathic pain.Two weeks after his pump was refilled, he was awoken by the sound of an alarm signal from his pump.He presented to a local emergency department where the device was interrogated and found to have a rotor stall.Referral was made to mayo clinic for possible withdrawal management and pump refill.Exact timeline details are in fig.1.Prior to transfer, his dose was changed from 38.307 mcg/day to 0.307 mcg/day to lower the risk of a possible overdose in the setting of a malfunctioning pump.No additional opioid was given at that time.At the time that he presented to our institution, he rated his pain at 6/10 and denied any dizziness, nausea, sweating, diarrhea, or myalgias.A physician examination revealed a well-healed abdominal scar with some scar tissue thought to be related to prior wound dehiscence.Interrogation of the pump revealed the lower dose of 0.307 mcg/day with an electric replacement indicator of 38 months.Drug was not being delivered despite an adequate reservoir volume, so the pump was deactivated and, again, it was thought to be related to a rotor stall malfunction.A fentanyl patch and patient-controlled analgesia (pca) were provided for pain control and to prevent withdrawal symptoms.He reported no withdrawal feelings with stable vital signs that led the team to believe that his pump may not have been working for some time.After discharge, he had continued pain but elected to keep the pump in place.Because the patient presented in this case report was receiving 1/100th of the dose prescribed, a major withdrawal would be expected.However, the contributory pharmacokinetics was such that this expected withdrawal was not observed.A dye study could have been performed to assess whether any medication was delivered; however, since our patient was not symptomatic and had decided to not continue with therapy, no additional root cause analysis was obtained.A recommendation was made for pump replacement and pain rehabilitation; however, our patient did not pursue either option.No cause was identified for the pump malfunction since the pump still remains in place several years later.The following device specifics were provided: synchromed iib.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer (Section G): RICE CREEK MFG; 7000 central ave ne; fridley MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9732727
• MDR Text Key: 186618291
• Report Number: 6000030-2020-00033
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• 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
• Date Manufacturer Received: 01/21/2020
• 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
• Patient Age: 50 YR