SynchroMed Infusion Pumps

It has been recently brought to public attention that the SynchroMed infusion pumps produced by Medtronic Inc. have been found to have serious flaws that have led to massive recalls.  The U.S. Food and Drug Administration (FDA) issued a Class I recall on the Medtronic SyncrhoMed infusion pumps.  The SynchroMed infusion pumps were originally designed with the intention of having a constant and reliable drug delivery system which would not require patients to routinely take their medication.  The device, surgically implanted onto the patient, offers months’ worth of automatically released medications directly into the patient’s bloodstream.

An article in the Wall Street Journal offered the disturbing news that has surrounded the recent concerns pertaining to the safety of the SynchroMed device.  The FDA issued an initial recall on the devices after serious complication arose due to defects in the products, on both mechanical as well as biological levels, in some instances resulting in the death of patients.  After the initial recall, the FDA reissued four total Class I recalls on the SyncrhoMed pump, signifying their urgency in the need to remove these devices.

The article makes mention of the disturbing fact that while current discoveries are being made indicating the dangers of the SynchroMed infusion pumps, Medtronic has not made efforts to inform the general public on the possible risks of their devices.  The article states that Medtronic released notices to medical professionals aimed towards informing doctors on the proper methods for ensuring the safe use of the SynchroMed device.  The fact remains that Medtronic has not made honest effort towards informing patients about the possible adverse effects and complications that coincide with the use of SynchroMed devices.

If you have experienced the complications that resulted from the implantation of a Medtronic SynchroMed device, then you deserve compensation for your suffering.  Contact our team of Synchromed lawyers and let us provide you with a free SynchroMed lawsuit consultation.

At your convenience, you may reach our offices either by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrus.us.  Call today and see how we can help!

In a current announcement recorded in the Star Tribune, Medtronic, Inc. reported that 14 total patient deaths have occurred in connection to their SynchroMed infusion pumps.  The deaths have been reported as occurring between spring of 1996 and spring of 2013.  The article reports that just one day prior to the public announcement from Medtronic, the U.S. Food and Drug Administration issued their highest priority Class I recall on SynchroMed infusion pump devices, indicating that “there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.” (emphasis added)

The deaths have been attributed to three major problems: first, several deaths were caused by medication being delivered to the tissue area surrounding the pump, rather than into the patient’s spinal fluid, as well as blockage in the pumps.  Secondly, one of the fourteen tragic deaths was attributed to a SynchroMed device short-circuiting.  Lastly, the devices have been observed as occasionally over-delivering or diluting medication because of the delivery method of the device to the catheter that sits under the patient’s skin.

The Star Tribune article states that Medtronic has made claims that they have warned patients about the potential dangers as well as issuing special detailed instructions to medical professionals who implant the devices as to ensure the safety of their product’s use.

The current controversy following the recalls for the SynchroMed infusion pump provide a clear example of the potential risks that patients face when given a device that has been deemed as potentially hazardous to their health.  If you or a loved one has been implanted with the SynchroMed infusion pump, then you may be at risk of suffering the potentially life-threatening complications caused by such products.  You may be eligible for a SynchroMed lawsuit, in which you may be compensated for the medical use of a dangerous device.  Contact us today and let us represent you to ensure that you receive the legal support you need to win justice for your suffering.

For more information regarding SynchroMed and SynchroMed lawsuits, or for a free case consultation, contact our team of Synchromed lawyers by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the experience, resources, and skills required to win the justice you deserve.

Recently, it has been reported that SynchroMed infusion pumps manufactured by Medtronic have been found to have four major flaws that have led to 14 patient deaths, leading to a massive FDA recall on SynchroMed devices.  In June, Medtronic notified customers about the flaws which may interfere with the safety and reliability of the SynchroMed infusion pump for the delivery of medications.  Each of the four flaws has led to a SynchroMed recall (Class I) by the FDA, meaning that the devices have potential life-threatening issues.

An article in BusinessWeek has reported that fourteen patients have died since 1996 while using the SynchroMed device, where, “The most common complication was the inadvertent injection of a drug into the patient’s subcutaneous tissue, rather than into the pump, which led to 11 deaths. Two patients died from a blockage and another from an electrical short.”

Issues may also stem from the SynchroMed’s priming feature, which allows for quicker drug delivery through the implanted catheter, as it allows for the possibility of either dilution of or over-delivery of medication.  Medtronic was reported to have recalled two types of devices in December as well, after reports of life-threatening consequences caused by improperly functioning devices and the use of unapproved drugs in the delivery systems.

The implications of these SynchroMed recalls are quite serious, with a primary complication being the death of patients.  It has been shown that not only can the devices fail on a mechanical level, they also can fail due to the improper use of unapproved drugs.  If you or a loved one has been used a SynchroMed infusion pump, then you may at risk of experiencing one of these serious complications, whether due to device failure or mistaken administration of drugs not safe for use with the SynchroMed.

Due to an exceedingly-high rate of failure associated with SynchroMed and the range of adverse events associated with the product, a number of SynchroMed lawsuits are currently being filed.  For a free, no-obligation case consultation, do not hesitate to contact our team of Synchromed lawyers at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the experience, skill, and resources required to win the justice you deserve.  Call today and see how we can help!

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.

(855) 452-5529
justinian@dangerousdrugs.us

Call today and see how we can help!

 

In recent news, there has been a massive mandatory recall for infusion pumps produced by the medical device company Medtronic.  These “SynchroMed” infusion pumps are implantable devices which release medication through a programmable administration system, allowing patients to undergo continuous medicative treatment without the need to orally or intravenously inject medication on a daily basis.  The recent recall by the U.S. Food and Drug Administration of SynchroMed pumps is due to unexplained complications that have led to at least 14 deaths tracing back to 1996 following its commercial release to the general market.

The alarming deaths related to the use of the SynchroMed infusion pump has led to the FDA labeling the defects as Class I recall, with the highest level of concern given a recalled product.  Additionally, a recent article on the InvestorPlace website shed light on problems with two separate pump models, both of which were recalled by Medtronic after being discovered as delivering improper dosages of medication.  The deaths that have been brought to the attention of the FDA were traced back to three significant problems related to the SynchroMed pumps.  The complications were as follows: 11 patient deaths after medication was injected into the patients’ tissue rather than into the pumps, two died from blockages, and one because of the device having an electrical short.

The current news indicates that 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 has received a Medtronic SynchroMed Infusion Pump, you may be at risk of suffering from one of the serious complications associated with SynchroMed.  Contact out team of Synchromed lawyers us to receive a free consultation and let us represent you in your pursuit of a SynchroMed lawsuit.

At your convenience, you may reach our offices either by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  Call today and see how we can help!