Medtronic is following up on a 2013 communication regarding the worldwide recall of its SynchroMed Implantable Infusion Pumps due to serious issues that can have fatal consequences for patients.
The issues involve three different devices – the Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pumps, and the Medtronic Sutureless Connector Catheter Products.
The SynchroMed II and the SynchroMed EL Implantable Drug Infusion Pumps contain and administer prescribed drugs to a specific site inside a patient’s body. Drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen, which are used to treat primary or metastatic cancer, chronic pain, and severe spasticity. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories.
The Sutureless Connector Catheter and Revision Kits are accessories to an implanted infusion system designed to store and deliver parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic SynchroMed implantable drug infusion pump and an Intrathecal Catheter. The Sutureless Revision Kit is used when a pump connector for an Intrathecal Catheter is required.
SynchroMed II and SynchroMed EL have two serious defects that can cause serious injury. First, there is a risk for patients to receive medication unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery. This unintended overdose or under dose of medication can lead to serious medical issues including respiratory depression, coma or death.
There is also the potential for an electrical shortage within the device that can cause the motor to stall or drain the battery which can lead to a loss or reduction in therapy, which could bring about the return of underlying symptoms and or withdrawal symptoms.
The Sutureless Connector Intrathecal Catheter Products affected by this recall have been redesigned to reduce the potential for occlusion, which is the blockage of a drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design and is recommending those products no longer be used. This defect may cause serious adverse events including drug under dose, loss of symptom relief, drug withdrawal symptoms, and death.
Medtronic’s latest update indicates that the company has updated the software application card for the SynchroMed Infusion Systems and labeling to address the priming bolus issue.
Any adverse events related to devices affected by this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.