Since the 1980s, the SynchroMed pump by Medtronic has been the leading intrathecal drug delivery system. The most recent model, the SynchroMed II, is designed to be a programmable drug delivery system that stores and delivers pain medication into the intrathecal space via a sub-dermal catheter. While the Synchromed II pump has been reported to have a high success rate and a range of safety features aimed at protecting the safety of the patient, there have been a range of adverse effects that occur as a direct result of the product, prompting a Class I recall of SynchroMed pumps by the United States Food and Drug Administration.
These adverse effects as mentioned by Medtronic include, but are not limited to:
“spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of, or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system component, pump inversion, technical/programming errors, or improper use, including use of non-indicated formulations and/or not using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection; anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious adverse effects from catheter placement in intravascular applications.”
Despite the benefits of using a drug delivery system like SnychoMed II such as consistent and accurate drug delivery, both the range of possible adverse events and the severity of those events are alarming. The numerous possible negative effects range from simple headaches to more serious complications such as systemic drug toxicity, not only caused by the intrathecal placement of the catheter, but by the administered drug as well.
The seriousness of these contraindications is too significant to ignore; if you have been implanted with a SynchroMed II intrathecal pump and have experienced any of the listed adverse effects, you may be the victim of the use of a dangerous medical device. Please contact our team of Synchromed lawyers to receive a free consultation to determine if you can file a SynchroMed lawsuit and be compensated for your suffering.
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