Medtronic Synchromed Pump Risks

The SynchroMed El infusion pump, made by Medtronic, has been recalled by the FDA over concerns that its motor is prone to failure. Drug pumps like the SynchroMed El are used to treat everything from pain to cancer, it's estimatd that around 8,000 patients currently have the models that are affected by the recall.

Background:

Another Medtronic product is the subject of a recall. Just a few months ago, the medical device manufacturer recalled 235,000 of its Sprint Fidelis defibrillator lead wires after they were linked to five deaths and many injuries. And over the past year they have been involved with lawsuits over Medtronic heart defibrillators that have faulty batteries, causing the battery to experience a rapid depletion of power resulting in the loss of device function.

Now Medtronic faces a Class I recall of their SynchroMed EL infusion pump. 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. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The device is implanted in the patient, either with or without a side catheter access port, catheters and catheter accessories. 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.

Affected devices

The following SynchroMed EL model numbers are part of the FDA’s Class I recall:

• 8626-10
• 8626L-10
• 8626-18
• 8626L-18
• 8627-10
• 8627L-10
• 8627-18
• 8627L-18

What can I do?

If you have experienced any adverse effects from use of a Medtronic SynchroMed EL Infusion Pump, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Stacy Hauer directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.