More than 50,000 patients worldwide have turned to the Medtronic Infusion Pump as a form of treatment for chronic back pain and severe spasms (chronic intractable spasticity). When working properly, the device, which is implanted either with or without a side catheter access port, delivers drugs to a specific site in the patient. Recent reports of defective equipment prompted and FDA recall earlier this year.
The FDA recalled the device on June 6, 2006, following reports of the catheter detaching from the pump, causing drug flow interruption. In a number of cases, this lead to loss of therapy, the return of the underlying symptoms and drug withdrawal (which can be fatal) in the patient. Medtronic sent a Medical Device Recall letter to healthcare providers following the FDA’s Class I recall, requesting all devices which were not yet implanted to be returned to Medtronic immediately.
The recall by the FDA was considered Class I, meaning there is reasonable probability that the continued use of the devices will cause serious adverse health consequences or death.
Pain Pumps and PAGCL
A recent study published by The American Journal of Sports Medicine identified popular pain pumps as the likely cause of a condition known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL).
Postarthroscopic Glenohumeral Chondrolysis specifically refers to the breakdown of cartilage in the shoulder joint following arthroscopic surgery. This devastating condition can cause severe pain and stiffness in the affected joints and muscles and can severely limit range of motion. It is not uncommon for patients suffering with PAGCL to require repeated surgeries, and the condition may ultimately require complete shoulder joint replacement surgery.
Symptoms of PAGCL include:
- Pain when the shoulder is in motion and/or at rest
- Clicking, popping and/or grinding,
- Weakness or stiffness in the shoulder,
- Decreased range of motion.
Pain Infusion Pumps
Implantable infusion pumps have been used for treatment for many who have had unsuccessful disk surgery or multiple operations on their back. It is also used for those suffering from the following back conditions:
- Degenerative Disc Disease
- Failed Back Syndrome (FBS)
- Peripheral causalgia
- Radical pain syndrome (radiculopathies)
- Arachnoiditis (lumbar adhesive arachnoiditis)
- Complex Regional Pain Syndrome (CRPS)
From the FDA
Programmable, implantable infusion pumps are regulated by the FDA as Class III devices. Class III is the strictest regulatory category of all medical devices, meaning that insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Pre-market approval is required to ensure the safety and effectiveness of Class III devices. Implantable infusion pumps that have not been granted approval by the FDA include:
- Synchromed Infusion Systems (Medtronic)
- InfusAid® Pump (Arrow International)
If you or a loved one have experienced any serious side effects from a Medtronic Infusion Pain Pump, please call us at (516) 342-2200 or fill out our online contact form for a free case evaluation.