Safety Alert: Urgent Medical Device Correction and Recall
FDA issued a class I recall of Medtronic’s SynchroMed II and SynchroMed EL implantable infusion pumps and refills kits. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. These pumps and refill kits have been recalled because pocket fills — the unintended injection of drugs or fluids into the tissue under the skin at the pump pocket site — have occurred and may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
Medtronic, which manufactures these pumps for the long-term infusion of pain, cancer treatment and anti-spasm medications, issued a “Urgent: Medical Device Correction” letter to health care providers on January 14, 2011. The letter reminded health care providers to check needle placement within the pump septum during the drug refill procedure — the needle must be inserted through the refill septum until it has reached the needle stop in the pump reservoir. Health care providers should review the signs and symptoms of drug overdose, underdose, and withdrawal with their patients and caregivers at EVERY refill.
The manuals for these pump and refill kits do include warnings related to the potential for improper injection; however, Medtronic is currently updating the labeling for the SynchroMed II and EL pumps and associated refill kits with more information for avoiding pocket fills and managing patients as recommended in the January 2011 letter to health care professionals.
The recalled products were manufactured from June 1998 to January 2003 and distributed from April 1999 to January 2011. They are:
- SynchroMed II (Model No: 8637)
- SynchroMed EL (Model No: 8626 and 8627)
- Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566)
For individuals who have an implantable infusion pump, the manufacturer’s make and model number can be found on your medical device information card. If you are have either a SyndroMed II or EL implantable infusion pump model listed above, notify the health care provider who is managing your infusion care for further instructions.
- Contact the FDA and report if you have had any adverse reactions such as pain, swelling or redness at the injection/refill site after a recent pump reservoir refill; loss of pain or spasm control; or excessive sleepiness, difficulty breathing, nausea, vomiting or itching. Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm; by regular mail to 5600 Fishers Lane, Rockville, MD 20852-9787; or by fax to (800) FDA-0178.
Consumers with questions may contact Medtronic Patient Services at (800) 510-6735, Monday - Friday, 8 a.m. to 5 p.m., central time for more information.
Health care professionals with medical questions related to this issue or Medtronic therapies should contact at Medtronic at (800) 328-0810, Monday - Friday, 8 a.m. to 5 p.m., central time.
From MEDPAGE TODAY, 17 FEB 2011:
According to Medtronic, from May 1996 to September 2010, there were eight deaths, 270 events requiring medical intervention, 58 events not requiring intervention, and 15 events of unknown severity related to pocket fills.
That works out to a rate as high as 1 per 10,000 refills, assuming pumps are refilled six times a year, the company said.
The recall affects model numbers 8637 (for SynchroMed II), 8626 and 8627 (for SynchroMed EL), and 8551, 8555, 8561, 8562, 8564, 8565, and 8566 (for the refill kits).
The products were manufactured from June 1998 to January 2003 and were distributed from April 1999 to January 2011.