The FDA has announced several medical device notifications due to problems with Medtronic‘s SynchroMed Implantable Infusion System, an intrathecal drug delivery system used to treat chronic intractable pain and severe spasticity of cerebral or spinal origin.
The agency has issued three Class 1recalls and one safety update to the pump refill procedure. The notifications relate to SyncroMed pumps used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin, and do not involve Medtronic external insulin pumps for diabetes, the agency noted in a press release.
The first recall is related to an error with the priming bolus function, which is used to move the drug from the pump reservoir to the catheter tip to achieve the requisite concentration of medication in the bloodstream when therapy is initiated.
The manufacturer has found that the drug mixes with the sterile water or cerebrospinal fluid already in the catheter, which results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus.This may increase the risk for over- or under-dosing following initial system implant or revision, according to the FDA.
In a letter to healthcare professionals, Medtronic has issued several recommendations for managing and monitoring patients after initiating intrathecal therapy as well as instructions for returning any explanted SyncroMed II pumps.
The second Class I recall is due to the potential for electrical shorting in the SyncroMed pump, which may result in a motor stall or decreased battery life. This may cause loss of or reduction in therapy. SyncroMed II pumps have since been equipped with a device alarm to alert patients of electrical shorts, according to the agency.
Medtronic estimates the overall device failure rate due to electrical shorting is less than 1% at seven years post-implant. “Because of the estimated low occurrence rate, the alarm safety feature and the risks associated with replacement surgery, Medtronic is not recommending removal of the devices unless a patient’s pump shows signs of a malfunction,” the FDA said.
The company is in the process of developing design updates to address this issue, and recommends clinicians monitor patients closely for return to baseline symptoms, which may indicate pump failure.
The final recall is due to a misalignment between Medtronic’s Sutureless Connector (SC) Catheter and the pump, which may stop the flow of medication. The catheter has since been redesigned, but the manufacturer is recommending healthcare providers discontinue the us of all SC Catheter models 8709SC, 8731SC, 8596SC and 8578 manufactured prior to the design change. These products are identified by a ‘use by’ date prior to August 25, 2014, according to the FDA.
All three defects were associated with the possibility of serious health consequences such as overdose, underdose, loss of symptom relief and death.
Medtronic also issued a pump refill procedure update, that will consist of distributing a revised Clinician Refill Reference Card to reflect new product labeling that will help clinicians reduce the potential for pocket fill.This is a continuation of a 2011 Class I recall related to the pump refill procedure.
“Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose,” the FDA advised.
by Walker Harrison, an undergraduate student at Columbia University and editorial intern with Clinical Advisor.