Medtronic SynchroMed II Implantable Drug Infusion and SynchroMed EL Implantable Drug Infusion pumps are being recalled in a Class I recall, the U.S. Food and Drug Administration (FDA) just announced. A Class I recall is the agency’s most serious designation and involves situations in which there exists a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
The following products and model numbers are being recalled:
- SynchroMed II: Models 8637-40 and 8637-20. The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.
- SynchroMed EL: Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18.
The recalled SynchroMed Infusion Pumps were manufactured May 1998-November 2012 and April 1999-November 2012. The SynchroMed Infusion Pumps contain and administer prescribed drugs or fluids to a specific site in a patient’s body. Approved drugs for use with the SynchroMed infusion pumps are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate, and Gablofen.
Medtronic Neuromodulation, located at 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568, issued the recall and recently notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact pump performance. Based on data from the firm’s Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump at 78 months post implant is 2.4 percent when used to dispense approved drugs, and 7.0 percent when used to dispense unapproved drugs. Medtronic Neuromodulation Technical Services may be reached, toll-free, at 1.800.707.0933, weekdays, 7:00am-6:00 p.m., Central Standard Time.
Use of unapproved drugs with the SynchroMed Infusion Pump can lead to intermittent or permanent pump motor stall and cessation of drug infusion, which may cause serious adverse health consequences, including death. Also, Medtronic reminded healthcare professionals that the SynchroMed pump can experience motor stalls when used with either approved or unapproved drugs; pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used.
Medtronic stated it continues to investigate motor gear corrosion, which has been identified as a primary contributor to permanent motor stall in the SynchroMed Infusion Pump. The agency also announced that, last month, Medtronic sent an Urgent Medical Device Safety Notification to healthcare professionals describing the issue and providing recommendations; physicians were asked to return a response form.
Medtronic recommended that healthcare professionals only use the approved drugs identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump. The agency warned that compounded drugs, unapproved concentrations, or unapproved formulations NOT be used with the SynchroMed Infusion Pump.
Health care professionals are advised to continue to monitor patients closely for the possible return of baseline symptoms—a return of baseline symptoms could potentially indicate pump damage—and to reinforce with patients and caregivers about the signs and symptoms of withdrawal due to therapy cessation, and the importance of contacting their healthcare professionals immediately if these signs and symptoms appear.
The SynchroMed II pump is designed with a critical alarm for pump motor stall. For patients implanted with a SynchroMed II pump, the critical alarm interval frequency can be changed to sound every 10 minutes. Patients, caregivers, and health care staff should be reminded to be alert for pump alarms. At implant or follow-up visits, an alarm test should be performed so patients and caregivers may hear and differentiate between critical and non-critical pump alarms. For patients with a Personal Therapy Manager (PTM), the PTM will show alarm code 8476 when a bolus is attempted if there is an active alarm.
Retrieve logs when interrogating the SynchroMed II pump to check for motor stall events. A temporary motor stall with recovery is expected behavior when the pump is exposed to a strong magnetic field such as during an MRI. Medtronic Technical Services can be contacted for further assistance evaluating motor stall events on logs.