FDA Warns of SynchroMed Pain Pump Injuries
UPDATED: June 19, 2018
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The FDA has issued a Class I recall after reports of Medtronic SynchroMed pain pump injuries - meaning there is a chance of serious injury or death. If you've been injured by a Medtronic SynchroMed II pain pump, contact an experienced product liability injury lawyer to discuss your situation and determine whether you might be entitled to compensation so that you can decide for yourself whether filing a Medtronic lawsuit might be in yourbest interests.
Medtronic Lawsuits Likely
Medtronic injury attorneys say that the U.S. Food & Drug Administration's (FDA) Class I recall of certain lots of Medtronic SynchroMed II pain pumps - used to deliver morphine sulfate and ziconotide for the treatment of chronic pain, intrathecal baclofen for severe spasticity and floxuridine and methotrexate for certain cancers - will likely lead to Medtronic injury lawsuits.
Here are the details on the SynchroMed II recall:
- Which SynchroMed II pain pumps are affected?The recall applies to SynchroMed II implantable pain pump models 8637-20 and 8637-40 which were distributed between 2004 and July of 2011.
- Why are certain SynchroMed II pumps defective?According to the FDA, the affected SynchroMed II pain pumps may, "fail to deliver drugs used to treat chronic pain, spasms and other conditions." At this time, there have been over 50 confirmed cases of medical device malfunction.
- What is a Class I recall?A Class I recall is the most serious recall available to the FDA - meaning that defective products have a 'reasonable probability' of causing serious adverse health consequences or death.
- How has Medtronic reacted? The Minneapolis Minnesota-based medical device giant notified doctors about SynchroMed side effects in July 2011 and has updated the pump's design since that time using a new battery design. The company urges SynchroMed II patients to "alert their physicians if their device alarms or if they experience a return of symptoms." However, it does not recommend removing the devices from patients already implanted with them if they are functioning properly.
Defective Pain Pumps
Medtronic's defective pain pumps have the capability of causing serious injury or death. If you've been injured by the SynchroMed II pain pump, contact an experienced Medtronic injury lawyer today to discuss your situation, determine whether you might be entitled to product liability compensation such as lost wages, medical bills and pain and suffering and decide whether taking legal action against the company is in your your - and your family's - best interests.