FacebookTwitterDiggGoogle BookmarksRedditRSS Feed

Medtronic Pain Pump


Medtronics Pain Pump Warning

If you are experiencing pain and you’re not responding to medication, your doctor may prescribe a drug pain pump.  These implantable devices send pain medication directly to the area of trauma providing pain relief with a small fraction of the medication needed if taken orally.  Medtronic, one manufacturer of pain pumps has had a number of setbacks with their pain pumps that have generated a number of Pain Pump Side effects.  These pain pumps are used to deliver morphine sulfate sterile solution to the spinal column to treat chronic pain as well as pain medications for the treatment of primary or metastatic cancer. 

A Medtronic Pain Pump Warning has been issued for non-indicated formulations that contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with the device and can damage the system.  Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with Medtronic systems or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risk to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under or overdose.  Physicians must be familiar with the drug stability to drug concentration and pump flow rate before prescribing a pump infusion. 

An inflammatory mass (seroma pocket) can result in serious neurological damage, including paralysis which may occur at the tip of the implanted catheter.  Physicians need to monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for dose changes.  Failure to recognize signs and symptoms and seek appropriate medical attention can result in serious injury or death.  Physicians need to instruct patients to notify them that they have an implanted pump before any medical procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult their doctor if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes.  Strong sources of electromagnetic interference such as short wave or MRI can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, or fatal drug under or overdose.  Drug infusion should be suspended during MRI procedures.  Physicians need to confirm pump status before and after MRI procedures.  Patients need to be monitored after device or catheter replacement for signs of under/overdose.  If you have experienced Pain Pump Side effects you might want to contact a Pain Pump attorney to be informed of your legal rights.

Pain Pump Warning Issued

Pain Pump Side effects include spinal/vascular procedure risks such as infection, bleeding, tissue damage, all of which may require additional surgical procedures.  Improper use of the device, failure of the catheter, programming errors, using inappropriate drugs or improper use may result in pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, meningitis, paralysis and device rejection.  A seroma is a pocket of clear fluid that can develop after surgery.  When small blood vessels are ruptured, blood plasma can seep out and inflammation occurs due to injured cells contributing to the clear fluid.  No red blood cells are found in this fluid just clear serous fluid.  If you have experienced any of these Pain Pump Side effects you should consult with a Pain Pump lawyer to discuss your legal rights in this matter.  Given that a Medtronic Pain Pump Warning and recall has been issued, lawsuits have been filed around the country.

Due to all these complications a Medtronic Pain Pump Warning was initiated by the FDA warning physicians and consumers about the numerous problems with this implant.  The Medtronic Pain Pump Warning alert has now become a Medtronic Recall in 2008.  Improper connections between the implanted catheters and pumps that deliver infused drugs have been detected in 83 patients where one patient died.  The FDA has classified this alert as a Class I Recall, which means a “reasonable probability” exists that use of this product may cause serious adverse health consequences or death.  Neither the FDA nor Medtronic require that the pump be removed from patients.  However, they recommended that patients who have recalled products be monitored closely.  These improper connections can result in leaks of pain drugs that can cause overdoses, under doses or return of symptoms that the medication is supposed to treat according to Medtronic.  These pumps are also used on patients who have spasticity related to cystic fibrosis, traumatic brain injury and multiple sclerosis as well as chronic pain.

The Medtronic Pain Pump Warning recall includes models:

  • Indura 1P Intrathecal Catheter, model 8709SC
  • Intrathecal Catheter, model 8731SC
  • Sutureless Pump Connector Revision Kit, model 8578
  • Intrathecal Catheter Pump Segment Revision Kit, model 8596SC

You May be entitled to Compensation, so act now.

Lawyer are now speaking with individuals who have been harmed after receiving a shoulder pain pump after surgery. According to the FDA some  injections given by infusion pain pumps has resulted in reports of chondrolysis,  a severe type of shoulder arthritis in which the cartilage of the joint is abruptly lost after shoulder arthroscopy. 

If you or a loved one has been injured as a result of a Medtronic Pain Pump installed in your shoulder, contact us now to speak with our qualified professionals about possible compensation.  Call us now at 877-222-7069 or use the contact form for a free case review.

Lawsuit Evaluation Form

Please provide us as much information as possible concerning the problems you are experiencing.

Evaluation Information

Please indicate the name of the drug or device. The more details the better.

What were the side effects?

Important Legal Disclaimer*

Our e-Newsletter

Stay up to date with the latest alerts, recalls and other useful information from RecallWarning by signing up to our free e-newsletter.

Latest FDA Alerts