Drug Infusion Pump Lawsuits: Medtronic SynchroMed II
Drug infusion pumps, also known as pain pumps, have been used for years to treat severe pain related to cancer and other chronic disorders. They are implanted under the skin and deliver pain medication directly to the spinal cord, providing much faster relief than oral medications. Drug infusion pumps are prescribed only when a patient does not respond well to traditional pain management or suffers from harsh side effects of oral medication. A widely used drug pump — the Medtronic SynchroMed II — has been linked to poor patient outcomes including overdose, underdose, withdrawal, and even death. Design flaws in the device are responsible for these outcomes.
Common Issues with the SynchroMed II
Claims are being made for two alleged design defects, “pocket fills” and battery failures. Pocket fills may prompt deadly overdoses when medicine is accidentally injected directly into the patient’s skin rather than into the device during a routine refill. In other cases, film buildup in the device’s battery compartment leads to compromised performance. Patients may not get a full dose of the medicine they need and suffer from severe pain or even dangerous withdrawal.
Symptoms associated with overdose, underdose, or withdrawal can include:
- Return of pain, spasticity, or other previous symptoms
- Dizziness or lightheadedness
- Drowsiness or loss of consciousness
- Low body temperature
- Low blood pressure
- Tingling sensations
A History of Problems
For patients with drug infusion pumps to thrive, dosing must always be accurate and consistent. Variation – even small changes in the amount of drug delivered – can lead to poor outcomes. For more than five years, the SynchroMed II has been associated with dangerous dosing variance. Medtronic, the device manufacturer, first warned physicians about potential problems in 2009. The company did not initially issue a recall and assured patients that they did not need to have their device surgically removed. However, due to continued problems, a Class I Recall was issued by the Food & Drug Administration (FDA) in 2011. Even after the recall, problems were seemingly left uncorrected, leading to the FDA’s 2015 decision to stop all sales of SynchroMed pain pumps. Hundreds of serious injuries and a handful of deaths have been reported.
Contact a Defective Medical Device Attorney
Were you, or someone you love, injured by the Medtronic SynchroMed II drug infusion pump? An attorney who is skilled and experienced in defective medical device litigation can help you understand your legal rights and in some cases, help you seek compensation for your injuries. Ward Black Law is located in Greensboro, NC, but available to help clients in all 50 states. Give us a call toll-free at (877) 256-1214 or contact us online.