Medtronic Drug Infusion Pumps: Recall - Intermittent or Permanent Pump Motor Stall

Medtronic Drug Infusion Pumps: Recall - Intermittent or Permanent Pump Motor Stall

SynchroMed II Implantable
SynchroMed EL Implantable
Audience: Risk Manager, Physical Medicine, Neurosurgery
ISSUE: FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump’s performance. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. A cessation of drug infusion may cause serious adverse health consequences, including death.
BACKGROUND: The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps contain and administer prescribed drugs or fluids to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen.
These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012. Model numbers can be found in the recall notice.
RECOMMENDATION: To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump. Do not use compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump

Refer to the Medtronic Medical Device Safety Notification , sent November 9, 2012 to healthcare professionals which includes detailed information about this issue. In addition to the Healthcare Professional Letter, the safety notification provided a white paper documenting the Increased Risk of Motor Stall and Loss of or Change in Therapy when Unapproved Drug Formulations are used with the SynchroMed Pump and a summary of the drugs that are approved to be used with the SynchroMed.
Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:



http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333251.htm

Related articles

• Resource4thePeople Offers Medtronic Infusion Pump Lawsuit referrals
• Nurses and Off Label Drug Use
• Medtronic Infuse Bone Graft Studies May Have Been Manipulated, According to U.S. Senate Report
• Healthpoint Whistleblower Case Settles for $48 Million
• U.S. Senate: Leading Medical Device Company Ghost-Wrote Articles, Paid Physicians : Consumer News : Medical Daily
• U.S. Barred From Prosecuting Off-Label Sales of Drugs
• FDA Has Been Approving Drugs It Hasn't Tested, Recalls Generic Version Of Wellbutrin XL
• White House Report Calls for Speedier FDA Approval of Drugs
• Drug industry's free speech helps doctors
• U.S. Senate: Leading Medical Device Company Ghost-Wrote Articles, Paid Physicians