Chronic pain or severe spasticity can be severely disabling. There is no question that these are conditions that need to be treated. People suffering from these conditions can be vulnerable, looking for anything to provide them relief.
Medtronic capitalized on this patient population.
About the Medtronic SynchroMed II Pump
The SynchroMed II Implantable Infusion Pump is a targeted-delivery pain pump. It’s implanted right under the skin in the patient’s abdomen and connected internally by catheter to the intrathecal space of the spine, directly to the pain receptors.
The pump is designed for nonstop delivery of powerful drugs into the patient.
The Synchromed II Pump has more than fifty separate component parts, essentially encased in titanium. The motor is gear-based and battery-operated, and it comes with an external programming device (like a tablet) that controls the rate of delivery of the medication by communicating with the pump’s microprocessor.
This implantable pain pump is a “peristaltic” pump, with a rotating motor that pushes the medicine through the catheter tube into the spinal column of the user.
The pump can be refilled with drugs (usually painkillers or spasticity medication, Baclofen) by a doctor or other clinician with a non-invasive injection under the skin into a port in the pump.
Additionally, the catheter can be accessed, also subcutaneously, by injecting dye to aspirate the tube or check for possible occlusions that may reduce the programmed delivery of medication.
The Medtronic SynchroMed II implantable infusion pump, Model 8637, comes in two sizes: Model 8637-20 and Model 8637-40, depending on the size of the medication reservoir. The 8637-20 holds 20 ml of medication, and the 8637-40 holds 40 ml.
Both can be extremely dangerous.
Reason for SynchroMed II Pump Recall
Since Medtronic announced FDA approval of its SynchroMed II Pump, there have been more than 19 FDA recalls and notice letters about malfunctions and patient dangers.
According to the FDA, Medtronic is recalling the SynchroMed II Pump because “a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine.”
During this time, patients may also “receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.”
People suffering from these conditions can be vulnerable, looking for anything to provide them relief. Medtronic capitalized on this patient population.
How Does the SynchroMed II Cause These Problems?
So, how does it happen?
Sometimes the motor stalls. Or the catheters become clogged. Or they disconnect from the rest of the pump.
Sometimes the battery goes out long before it’s supposed to. Or the software misdirects the medication, causing overdosing or insufficient medication delivery.
It could be that the priming bolus fails. Sometimes the pump short circuits in the “feed-through” of the pump, the hermetically sealed electronic connection between the motor and the software inside the pump. The short circuiting can cause a permanent motor stall.
Most importantly, none of these things are supposed to happen! And all of them can lead to serious injury.
Medtronic SynchroMed II Approved Uses
The SynchroMed II pump system was approved by the FDA for three limited purposes, two of which include treatment of pain, and one for the treatment of spasticity.
First, the pump can be used for the delivery of preservative-free morphine sulfate solution less than or equal to 25 mg/ml or Prialt (preservative-free ziconotide sterile solution), both for the treatment of intractable chronic pain.
Second, the pump is approved for delivery of methotrexate for the treatment of pain associated with primary or metastatic malignant cancer.
Third, and finally, the infusion system is approved for delivery of Lioresal (Baclofen) for treatment of severe spasticity. No other uses have been approved by the FDA. Any other use is deemed off-label, or unapproved.
Medtronic SynchroMed II Pump Side Effects
Medtronic continues to sell and promote this device even though the SynchroMed II Pump has been associated with the following serious conditions:
- Inflammatory masses (granuloma)
- Decreased therapeutic response/inadequate pain relief
- Pain — insufficient pain relief
- Neurological deficit/dysfunction
- Weakness/muscle weakness
- Difficulties walking or standing
- Return or worsening of spasticity
- Emergency surgery to remove the pump
FDA Action Against Medtronic SynchroMed II
The FDA has taken action against Medtronic for the SynchroMed II pain pump. There have been at least 19 recalls or instruction notices from the FDA or commanded by the FDA.
In 2017, the United States Department of Justice and Medtronic entered into an agreement — a “Consent Decree” — in which Medtronic agreed to change its behavior in connection with this device.
This was a major move by the Department of Justice, one reserved for medical device manufacturers who need direct supervision to protect patient safety. Medtronic knew it was falling short of its mark with the dangerous SynchroMed pain pump, and it knew it was putting patients in great danger with their inattention and unwillingness to comply with the legal requirements.
Hiring An Attorney for a Medtronic SynchroMed II Lawsuit
Our attorneys are currently evaluating and investigating claims on behalf of patients who have suffered serious side effects as a result of using the SynchroMed II pump. If you have been diagnosed with any of the serious conditions listed above after using a Medtronic SynchroMed II pump, please contact us immediately.
In many cases, filing a lawsuit is the only way to recover money that is lost from hospital stays, lost wages, and for some – funeral costs.
Van Wey Law Can Help, No Matter Where You Live
To discuss the specifics of your potential Medtronic lawsuit in a free and confidential consultation, contact us today. You may also call us at 1(888)-694-8093.
During your free case evaluation we will determine if you may be entitled to receive compensation from this irresponsible medical manufacturer who places profit over public safety.