Medtronic Neuromodulation SynchroMed and IsoMed Implantable Infusion Pumps
- decreased therapeutic response/inadequate pain relief (reported in 33.5 percent of patients),
- pain (reported in 32.6 percent of patients), and
- neurological deficit/dysfunction (reported in 17.4 percent of patients).
Inflammatory mass formation has been associated with a wide range of doses and concentrations of opioids, and no dose and/or concentration of morphine sulfate can be considered completely free of risk. The risk appears to be cumulative over time and increases with higher concentrations of opioids. Therefore, intrathecal opioids should be administered to achieve adequate analgesia for as long as possible at the lowest effective dose and concentration.
Recommendations for Patient Management
Individual patient susceptibility to inflammatory mass cannot be predicted. Diligent patient management and increased awareness of inflammatory mass symptoms are essential. In patients with new neurological signs or symptoms, consider neurosurgical consultation and the prompt performance of an imaging procedure to confirm or rule-out an inflammatory mass.
- When administering intrathecal opioids, administer the lowest effective dose and concentration.
- In patients treated with intrathecal baclofen therapy, monitor them to identify the prodromal clinical signs and symptoms of inflammatory mass, especially if using pharmacy-compounded drugs or baclofen admixtures that include opioids.
- In patients with new neurological signs or symptoms, consider neurosurgical consultation and prompt performance of an imaging procedure to confirm or rule-out an inflammatory mass.
For Assistance and a Sample Informed-Consent Document
For a copy of the sample informed-consent document, visit our resource center at www.thedoctors.com/consent.
Medtronic Neuromodulation Technical Services can be reached at (800) 707-0933. Additional information, including links to references and abstracts, can be found at www.medtronicconnect.com. Medtronic’s January 2008 letter to physicians about inflammatory mass can be found at www.medtronic.com/im.
Summary of Symptoms Reported for Cases of Inflammatory Mass
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Informed Consent
It is important to inform patients of the potential for serious complications associated with intrathecal drug infusion, including the use of the SynchroMed® and IsoMed® implantable infusion pumps. The informed-consent discussion should include disclosure of the symptoms listed in the table shown above, especially neurological deficits and dysfunctions that have been reported. This discussion should be documented in the medical record. It is recommended that all patients have an updated, signed informed consent in their medical record, including patients who have been using the pump. An updated informed-consent conversation should be held at the earliest practical time.
Suggested Informed-Consent Language
Formation of an inflammatory mass (granuloma) at or near the tip of intrathecal catheters has been reported with the intrathecal infusion of opioids, baclofen, pharmacy-compounded drugs, and other pharmacological admixtures—particularly when administered in relatively high doses and/or high concentration. The reported incidence is as high as 3 percent. Some cases occur within six months, while others occur as long as 10 or more years after starting opioid therapy. Granuloma formation has been associated with a wide range of doses and concentrations of opioids, and no dose and/or concentration can be considered completely free of risk. The risk appears to be cumulative over time and increases with higher concentrations. Individual patient susceptibility to inflammatory mass cannot be predicted.
- decreased therapeutic response/inadequate pain relief (reported in 33.5 percent of patients),
- pain (reported in 32.6 percent of patients), and
- neurological deficit/dysfunction (reported in 17.4 percent of patients).
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