Do you or a family member need a Medtronic Pain Pump Recall Lawsuit Lawyer? The Law Firm of Schneider Hammers in Atlanta is now accepting certain cases that involve patients who suffered severe side effects due to the SynchroMed II implantable infusion pump. For a confidential and free consultation to discuss the details of your potential Medtronic lawsuit, please get in touch with the personal injury attorneys at Schneider Hammers.
- 1 What is the SynchroMed II Pain Pump?
- 2 Why Has the SynchoMed II Pump Been Recalled?
- 3 What Uses of The Medtronic SynchroMed II Have Been Approved by the FDA?
- 4 What Side Effects Are Associated?
- 5 What FDA Action Has Occurred?
- 6 Hire Schneider Hammers for Your Medtronic SynchroMed II Lawsuit
What is the SynchroMed II Pain Pump?
This medical device is a targeted-delivery type of pain pump. It is implanted directly underneath the skin of the abdomen of the patient and interconnected to the spine’s intrathecal space by catheter, and directly into the pain receptors.
This pump has been designed for dering powerful drugs to the patient on a continuous basis. The Synchromed II Pump has over fifty separate component parts that are basically encased in titanium. It features a battery-operated and gear-based motor and provides an external programming device (such as a tablet) for controlling the medication’s delivery by communicating with the microprocessor in the pump.
The implantable pain pump is a type of “peristaltic” pump that has a rotating motor that works to push medicine through a catheter tube into the patient’s spinal column.
The pump may be refilled with drugs (normally spasticity medication such as Baclofen or painkillers by a clinician or doctor with a non-invasive injection underneath the skin into the pump’s port.
Also, the catheter may be accessed, subcutaneously as well, by dye being injected in order to aspirate the tube or to check for potential occlusions that might reduce the medication’s programmed delivery.
Model 8637 of Medtronic’s SynchroMed II pump is available in two different sizes: Model 8637-40 and Model 8637-20, depending on the medication reservoir’s size. The 8637-40 pump holds 40 ml and the pump 8637-30 holds 20 ml.
Both of them can be very dangerous.
Why Has the SynchoMed II Pump Been Recalled?
Since Medtronic announced its SynchroMed II Pump being approved by the FED, there have been over 19 FDA notice letters and recalls about patient dangers and malfunctions.
The FDA reported that the SynchroMed II Pump is being recalled by Medtronic because of a software problem that might cause the unintentional delivery of drugs via a priming bolus procedure that is being used to deliver large medication doses quickly from the device to the spine of the patient.
During that time, patients might also unintentionally receive the drug at a high infusion rate within the cerebrospinal fluid which is followed by a reduced drug delivery period following the priming bolus. That can result in either a drug underdose or overdose which may result in serious adverse health consequences, including death, coma, or respiratory depression.
How Do Problems With The SynchroMed II Arise?
So, how does this occur? The motor stalls sometimes. or the catheters can become clogged. Or they become disconnected from the pump.
At times the battery goes out well before it is intended to. Or the pump’s software may misdirect the medication, which causes insufficient medication delivery or causes overdosing.
The priming bolus may fail. At times the pump will short circuit in the pump’s feed-through, which is a hermetically sealed electronic connection that is between the software and motor inside of the pup. A permanent motor stall can be caused by short-circuiting.
Most important, none of those things are supposed to occur. And they can all result in serious injuries.
What Uses of The Medtronic SynchroMed II Have Been Approved by the FDA?
The FDA approved the SynchroMed II pump system for three limited purposes. One is for treating spasticity and the other two are for treating pain.
First of all, the pump may be used for delivering a morphine sulfate preservative-free solution that is equal to or less than 25 ml/mg or Prialt (a sterile preservation-free ziconotide solution) for treating intractable chronic pain.
The pump was also approved for delivering methotrexate for treating pain associated with metastatic or primary malignant cancer.
Finally, the infusion system has been approved for delivering Lioresal (Baclofen) for treating severe spasticity. The FDA has not approved any other uses. Any other use is considered to be unapproved or off-label.
What Side Effects Are Associated?
Medtronic has continued selling and promoting this device despite the fact that the SynchroMed II Pump has been linked with these serious conditions:
- Emergency surgery for removing the pump
- Worsening or return of spasticity
- Difficulties standing or walking
- Muscle weakness/weakness
- Neurological dysfunction/deficit
- Pain/insufficient pain relief
- Inadequate pain relief/decreased therapeutic response
- Granuloma (inflammatory masses)
What FDA Action Has Occurred?
For its SynchroMed II pain pump, the FDA has taken action against Medtronic. The FDA has issued at least 19 instruction notices or recalls.
An agreement was entered into by Medtronic and United States Department in 2017 – a “Consent Decree” – where Medtronic agree to alter its behavior associated with the device.
This was a significant move that the Department of Justice made, which is one that is reserved to be used with medical device manufacturers who are in need of direct supervision in order to protect the safety of patients. Medtronic was aware that is falling short and that its SynchroMed pain pump was dangerous. It also knew it was placing patients in serious danger with its unwillingness to comply with its legal requirements and its inattention.
Hire Schneider Hammers for Your Medtronic SynchroMed II Lawsuit
Currently, our attorneys are evaluating and investigating claims for patients who have suffered severe side effects from using a SynchroMed II pump. Please contact Schneider Hammers right away if you have diagnosed with any of the above serious conditions after you used a Medtronic SynchrMed II pump.
Filing a lawsuit, in many cases, is the way you can recover money that has been lost from lost wages, hospital stays, or funeral expenses.
Please contact us today to discuss the specifics of a potential Medtronic lawsuit with a confidential and free consultation. You can call us at 1 (678) 846-6900.
During your free consultation and case evaluation, we will determine whether or not you are entitled to receive compensation from Medtronic, an irresponsible medical manufacturer that has placed profit over public safety.