Recall Class: Class I
Date Recall Initiated: June 3, 2013
Products: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps
- SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
- SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size)
This recall does not affect Medtronic external insulin pumps for diabetes.
These recalled products were manufactured from May 1998 through June, 2013 and distributed from April 1999 through June 2013.
Use: The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The SynchroMed pumps 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.
Medtronic, Inc. Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Medtronic Puerto Rico Operations Co.
50 Road 31 km 24.4 Ceiba Norte Ind Park
Juncos, Puerto Rico 00777
Reason for Recall: There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy. This may result in the return of underlying symptoms and/or withdrawal symptoms. Use of this recalled product may result in serious adverse health consequences, including death.
Public Contact: For questions about this recall, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.
FDA District: Minneapolis District Office
Patients: Maintain regular follow-up appointments with your physicians. However, if you experience a change or return of symptoms or hear a device alarm, contact your physician immediately.
Physicians: No action is required beyond the recommendations provided in the Urgent Medical Device Correction letter.
On June 3, 2013, Medtronic sent an "Urgent: Medical Device Correction" letter dated May 2013 to all affected customers. The letter described the issue of a pump’s potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations.
The firm is asking health care providers to return any explanted SynchroMed II implantable infusion pump to Medtronic Returned Products Analysis.
These actions are not expected to cause a device shortage.
Customers can contact their Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933 Monday through Friday, 7 AM through 6 PM Central Standard Time.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.