Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause too much or too little of a drug to be delivered from the device to the patient’s spine. The U.S Food and Drug Administration (FDA) has categorized this as a Class 1 recall. Class 1 indicates there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” and is the most serious type of recall, according to the FDA.
The recall involves the SynchroMed EL and SynchroMed ll pumps, which are programmed by a clinician to transport prescribed drugs to particular parts of the body. A recall does not require market withdrawal, but refers to a company’s corrective action. Therefore, the SynchroMed pumps remain on the market.
The national personal injury law firm Parker Waichman LLP has extensive experience in medical device litigation. Attorneys at the firm are available to answer any questions about filing a potential lawsuit.
Purpose of the Medtronic Infusion Pump
For patients with chronic pain or severe spasticity, intrathecal drug delivery (injection of a medication into the sheath surrounding the spinal cord), may be an important treatment. This is helpful, for example, to patients who have experienced intolerable side effects with oral medications.
Part of the SynchroMed ll system, the pump, stores and delivers pain medication by way of a catheter implanted under the skin. The software problem allegedly could cause an unintentional dose of drugs during a priming bolus procedure, which is meant to quickly send a large dose to the patient’s spine.
Medtronic Infusion Pump Complications
According to the FDA, an over or under-dose of a medication could lead to respiratory depression, a dangerously slow breathing rate, coma, or death.
An Urgent Medical Device Correction notice was issued by Medtronic in September 2016. It indicated a software update and changes in labeling and made improved priming bolus recommendations. Customers received revised cards designed to inform recipients of the corrections in warning for potentially unintended dosage during a procedure.
The Medtronic SynchroMed ll Infusion Pump has been plagued with numerous problems over the last few years, which have caused many users to suffer serious and potentially life-threatening health issues.
In February 2011, the FDA issued a Class 1 Medtronic SynchroMed pump recall following reports that physicians were accidentally injecting drugs directly into patients’ subcutaneous (under the skin) tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical treatment.
In September 2011, A SynchroMed ll battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. That was categorized as a Class 1 recall, as well.
In July 2012, a warning letter from the FDA was sent to Medtronic over the infusion pumps ordering the company to put in place a plan to correct the reported failure problems. The FDA had received 567 complaints concerning motor corrosion in the SynchroMed ll pump between then and October 2007. The corrosion caused gears to lose teeth, which led to the motor seizing up.
In 2012, a patient sued Medtronic alleging that a defective SynchroMed pump left him paralyzed. The plaintiff maintained that if the manufacturer had immediately reported manufacturing issues to the FDA, doctors and patients could have chosen not to use the device and his paralysis would not have happened
During the summer of 2012, the FDA issued a warning letter to Medtronic over SynchroMed production alleging it fell short of fully addressing the risk of corrosion in the devices.
A complaint filed in the U.S. District Court for the Middle District of Pennsylvania alleged that the Medronic SynchroMed ll was defectively designed and prone to malfunctions that may cause serious medical problems. The plaintiff had a Medtronic SynchoMed ll pump implanted in his abdomen in December 2012, for treatment of chronic pain. The pump was meant to deliver controlled levels of pain medications into the intrathecal space of his spine.
However, in the summer of 2014, the Synchromed pump malfunctioned and overdelivered medication, causing severe pain, nausea, and a lack of mobility that required hospitalization.
In April 2015, the FDA finally entered into a consent decree with Medtronic over the repeated errors and manufacturing problems which required the company to cease manufacturing, designing and distributing new Medtronic SynchroMed ll infusion pumps, except in cases where a doctor determined it was medically necessary for a patient’s treatment.
“Throughout the history of the manufacture of the SynchroMed ll Device, Medtronic has shown an indifference to federal manufacturing requirements,” the lawsuit states. “Further, Medtronic, with full knowledge that they were manufacturing the SynchroMed ll Device in violation of the law, nonetheless demonstrated a pattern of delayed responses or complete failures to respond to reported and known safety issues with the SynchroMed ll Device.”
Advice and Information for Medical Device Problems
If you or someone you know suffered injuries regarding the use of a Medtronic SynchroMed Device, you may have valuable legal rights. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).