The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product: SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump
- Product Code: LKK
- Model Numbers: 8637-20, 8637-40, 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18
- Manufacturing Dates: September, 2013 to October, 2016
- Distribution Dates: September, 2013 to October 3, 2016
- Devices Recalled in the U.S.: 14,499 Model 8870 software application cards (version AAR01)
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) are programed to deliver prescribed drugs to a specific site inside the patient’s body. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity.
Reason for Recall
Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
On October 7, 2016 Medtronic initiated an update recall to communications issued on May 14, 2013. Medtronic made a software change to the Synchromed II application contained on the Model 8870 software application card. This change will correct the priming volume associated with the priming bolus function. They also updated the labeling related to the software change and priming bolus function.
Who May be Affected
- Health care providers using the SynchroMed Implantable Infusion Pumps
- All patient groups undergoing Priming Bolus procedures involving the SynchroMed Implantable Infusion Pumps
What to Do
In September 2016, Medtronic sent an Urgent Medical Device Correction notice to affected customers. The notice provided a description of the software change, description of labeling changes, 8870 software card recommendations, and new priming bolus recommendations.
The notice also asked customers to:
- Continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card (new version is AAU0).
Medtronic Representatives began visiting affected customers on October 3, 2016 to replace software application cards with the updated version (AAU01).
Customers are instructed to contact Medtronic Neuromodulation Technical Services by telephone at 1-800-707-0933 with any questions related to this recall.
Date Recall Initiated:
October 3, 2016
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.