In 2012, there was a massive mandatory recall of SynchroMed Infusion Pumps manufactured by Medtronic. These infusion pumps are implanted under the skin that release medication through a programmable administration system, allowing patients to undergo continuous medicative treatment without the need to take medicine orally or by intravenous injection daily.
Due to allegations that SynchroMed Infusion Pumps were known by the manufacturer to carry risks long before the recall was initiated, infusion pump lawsuits have been filed across the country. If you or a loved one used a SynchroMed Infusion Pump and suffered adverse side effects, you may be entitled to substantial financial compensation through a SynchroMed Infusion Pump lawsuit. For a free consultation, contact our team of SynchroMed Infusion Pump lawyers today.
Fatalities Linked to SynchroMed Infusion Pumps
The recall by the U.S. Food and Drug Administration of SynchroMed pumps came about after a slew of unexplained complications that have led to at least 14 deaths following the product’s 1996 commercial release.
The alarming deaths related to the use of the SynchroMed infusion pump led to the FDA labeling the defects as Class I recall, which is the most serious recall classification. These fatalities were traced back to three significant problems related to the SynchroMed pumps: 11 patients died after medication was injected into the patients’ tissue rather than into the pump’s port, two died from blockages, and one because the device had an electrical short.
SynchroMed Infusion Pump Complications
While the Synchromed II pump has been reported to have a high success rate and a range of features to ensure patient safety, there have been a range of adverse effects linked to these products.
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.” (emphasis added)
SynchroMed Infusion Pump Lawsuits
Current research demonstrates the SynchroMed pump is not yet safe for commercial use, causing rise to belief in the necessity of further research and development for Medtronic SynchroMedinfusion pumps. If you or a loved one used a SynchroMed Infusion Pump, you may be at risk of suffering from one of the serious complications associated with SynchroMed, and eligible for substantial financial compensation through a SynchroMed lawsuit.
For a free, no-obligation consultation, contact our team of Synchromed lawyers at Dangerous Drugs. We have the experience, resources, and compassion required to win the compensation you deserve. Call today and see how we can help!