Medtronic Synchromed Pain Pump failure. According to a warning notice sent to doctors by the Medtronic, some older Medtronic Synchromed II pain drug infusion pumps may have a failure rate that is greater than three percent. The implanted pain pumps fail prematurely because of battery problems.
Medtronic “Dear Doctor Letter”
Recently Medtronic sent out a “Dear Healthcare professional” letter, updating a SynchroMed II infusion pump recall originally issued in 2011. Medtronic has a product lookup site to check if the battery pack is at risk of failure.
Back in 2011, the Medtronic Synchromed II pumps were recalled because a film could develop on the batteries, causing the pump device to fail. There were over 55 battery failure problems at the time of the recall, and the defect caused at least one patient death.
Medtronic found that the highest risk of failure was in their Model 8637 pumps made in January 2011 through June 2011. Because of battery failure, the Model 8637 pumps devices have been linked to a 3.17% cumulative probability of pump failure at 72 months after implant.
What is the SynchroMed II Pump?
The Medtronic SynchroMed II infusion pump, known as a pain pump, is a medical device that is implanted surgically. The Medtronic SynchroMed II infusion pump uses a plastic tube or catheter to deliver pain medication near the patient’s spinal cord.
The battery powered Medtronic SynchroMed II infusion pump is implanted under the skin. The pump is used to treat patients with primary or metastatic cancer, severe muscle spasms, chronic pain, and other severe painful health conditions.
The SynchroMed II was approved by the U.S. Food & Drug Administration (FDA) in 2004, and there are currently about 270,000 of the pumps on the market.
A Plague of Medtronic SynchroMed II Failures
The Medtronic SynchroMed II Infusion Pump line has a checkered history with severe and catastrophic problems over the last several of years, which have caused many patients to develop life-threatening health side effects and have resulted in several deaths.
In February 2011, the FDA declared a Class I Medtronic Synchromed pump recall after reports that doctors were injecting drugs directly into patients’ subcutaneous tissues while trying to refill the pump devices. These “pocket fills” caused at least eight deaths and 270 injuries requiring hospitalization.
In July 2012, the FDA sent another warning letter to Medtronic over the infusion pumps, ordering Medtronic to put in place a plan of action to deal with reported failure problems.
FDA Medtronic Consent Decree April 2015
The FDA after a detailed investigation agreed to a consent decree with Medtronic over the on-going multiple errors and manufacturing problems in April 2015. Under the agreement, Medtronic agreed to stop making, designing and distribution of new Medtronic Syncromed II infusion pumps.
September 2016 Class 1 Recall
But that was not the end of the problems, Medtronic sent out yet another Urgent Medical Device Communication in September 2016, warning that some Synchromed II and SynchroMed EL implants could inject patients with drugs at a high rate of infusion, resulting in a pain drug overdose or underdose.
The FDA classified this as a Class I recall, warning that it could cause serious adverse health conditions, such as respiratory depression, coma or death.
In September 2016, Jason Silver from Pennsylvania filed a Medtronic Synchromed II lawsuit over an over-infusion incident that left him injured after the pump device allegedly overdosed him on pain medications delivered to his spine.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured or died as result of a Medtronic pain pump malfunction, you should contact Dr. Shezad Malik law firm immediately at 888-210-9693. You may be entitled to compensation by filing a suit against the Medtronic and our lawyers can help.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.