Medtronic Drug Infusion Pump Recalls: Frequently Asked Questions
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Medtronic Drug Infusion Pumps have been the cause of hundreds of adverse event reports to the FDA. The medical device manufacturing company recently recalled three of their devices, the SychroMed II, SynchroMed EL, and refill kits for potentially fatal defects. A few of the frequently asked questions are answered below:
What is a drug infusion pump?
Drug pumps are implantable devices used to administer medication directly into the area the patient requires treatment. Drug infusion pumps are frequently used in patients suffering from severe spasticity, cancer, and chronic pain because the pumps can be used to deliver medication to any part of the body, including the spinal cord.
Why were the Medtronic SynchroMed products recalled?
Although the SycnhroMed products have been recalled on several occasions, there were two defects that led to the Medtronic drug pump recalls in 2011. On January of 2011, the SynchroMed II, SynchroMed EL, and refill kits were recalled due to labeling defects that increased the incidence of pocket fills. A second recall followed months later in September, for battery performance issues that affected the SynchroMed II pumps. Medtronic analysis discovered battery issues that interrupted the regular medication of patients.
What is a “pocket fill”?
Pocket fills are failed refill procedures where the medication refill is injected into the drug pump pocket, rather than the pump reservoir. Sometimes, the clinician may even inject the full refill directly into the patient, causing a massive overdose. In the event of a pocket fill, the pump would never have been refilled, causing under-medication and even a complete stop in therapy.
What is a Class I recall and why is it important?
All of the Medtronic SynchroMed recalls, including the two from last year, have been Class I recalls; meaning that the continued use of the recalled medical device could foreseeably cause serious injury and even lead to fatality. The defects in the recalled SynchroMed products can result in inadequate medication or a sudden cessation of treatment and result in serious health complications.
What rights do I have if I have been injured by a recalled Medtronic drug infusion pump?
Patients who have suffered adverse events may be eligible to hold Medtronic liable for the damages related to their defective pump. A product liability claim can help patients recover the financial reparations they deserve for the injuries they sustained. If Medtronic refuses to offer you a fair settlement it may be necessary to entrust your case to an experienced defective medical device lawyer.
How can a product liability lawyer help me?
A professional product liability lawyer is skilled in handling large manufacturing companies such as Medtronic can help you determine the full value of your claim and your legal options. If a fair settlement is not forthcoming, your attorney can file a lawsuit against Medtronic for the damages you deserve to be compensated for.
ABOUT THE AUTHOR: Mike Bomberger
Product liability law is so challenging because manufacturing companies are heavily invested in defending their products. However, Mike and other lawyers at the law firm of Estey & Bomberger, LLP have successfully represented countless defective product victims at the negotiation table as well well as in the courtroom. For more information on drug pump lawsuits, please contact our attorneys for a free case review.
Copyright Estey & Bomberger, LLP
More information about Estey & Bomberger, LLP
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.
Drug pumps are implantable devices used to administer medication directly into the area the patient requires treatment. Drug infusion pumps are frequently used in patients suffering from severe spasticity, cancer, and chronic pain because the pumps can be used to deliver medication to any part of the body, including the spinal cord.
Why were the Medtronic SynchroMed products recalled?
Although the SycnhroMed products have been recalled on several occasions, there were two defects that led to the Medtronic drug pump recalls in 2011. On January of 2011, the SynchroMed II, SynchroMed EL, and refill kits were recalled due to labeling defects that increased the incidence of pocket fills. A second recall followed months later in September, for battery performance issues that affected the SynchroMed II pumps. Medtronic analysis discovered battery issues that interrupted the regular medication of patients.
What is a “pocket fill”?
Pocket fills are failed refill procedures where the medication refill is injected into the drug pump pocket, rather than the pump reservoir. Sometimes, the clinician may even inject the full refill directly into the patient, causing a massive overdose. In the event of a pocket fill, the pump would never have been refilled, causing under-medication and even a complete stop in therapy.
What is a Class I recall and why is it important?
All of the Medtronic SynchroMed recalls, including the two from last year, have been Class I recalls; meaning that the continued use of the recalled medical device could foreseeably cause serious injury and even lead to fatality. The defects in the recalled SynchroMed products can result in inadequate medication or a sudden cessation of treatment and result in serious health complications.
What rights do I have if I have been injured by a recalled Medtronic drug infusion pump?
Patients who have suffered adverse events may be eligible to hold Medtronic liable for the damages related to their defective pump. A product liability claim can help patients recover the financial reparations they deserve for the injuries they sustained. If Medtronic refuses to offer you a fair settlement it may be necessary to entrust your case to an experienced defective medical device lawyer.
How can a product liability lawyer help me?
A professional product liability lawyer is skilled in handling large manufacturing companies such as Medtronic can help you determine the full value of your claim and your legal options. If a fair settlement is not forthcoming, your attorney can file a lawsuit against Medtronic for the damages you deserve to be compensated for.
ABOUT THE AUTHOR: Mike Bomberger
Product liability law is so challenging because manufacturing companies are heavily invested in defending their products. However, Mike and other lawyers at the law firm of Estey & Bomberger, LLP have successfully represented countless defective product victims at the negotiation table as well well as in the courtroom. For more information on drug pump lawsuits, please contact our attorneys for a free case review.
Copyright Estey & Bomberger, LLP
More information about Estey & Bomberger, LLP
View all articles published by Estey & Bomberger, LLP
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.
