FDA MedWatch- FDA MedWatch- Medtronic Inc. SnychroMed EL Implantable Infusion Pump - Class I Recall
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramROCKVILLE, Md., Feb. 4, 2008--FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Class I Recall Notice regarding this below:
Class 1 Recall: Medtronic Inc. SynchroMed EL Implantable, Infusion Pump
|
Date Recall
Initiated |
August 3, 2007 |
|---|---|
|
Product:
|
Medtronic Inc. SynchroMed El Implantable, Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. SynchroMed El pumps with motors manufactured before September 1999 are affected. |
|
Use:
|
This device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. |
|
Recalling Firm:
|
Medtronic Neuromodulation 800 53rd Ave NE PO Box 1250 Minneapolis, Minnesota 55440-1250 |
|
Reason for Recall:
|
There is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors that were manufactured before September 1999. These pumps can stall at a higher rate due to gear shaft wear. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug underinfusion or withdrawal. Drug withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient’s spine) can cause death if not treated immediately and effectively. |
|
Public Contact:
|
Consumers with questions may contact Medtronic Neuromodulation Patient Services at 1-800-510-6735. Customers with technical questions may contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. |
|
FDA District:
|
Minneapolis |
|
FDA Comments:
|
Beginning on August 3, 2007, Medtronic Inc. notified their customers with a letter entitled, "Urgent: Medical Device Correction, Aug. 2007." This letter described the problem and the affected devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
|
Pharma Industry News Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
