Philadelphia personal injury lawyers advise patients of 14 deaths related to the use of Medtronic Inc.’s SynchroMed Implantable Infusion System. The infusion pumps were found to have four flaws that caused the deaths. The most frequent 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 other patients died from a blockage and another died because of an electrical short. The SynchroMed infusion pump is an implantable device used to deliver pain and other medications.
Reports indicate that another function on the infusion pump may also be causing injuries to patients. The SynchroMed infusion pump has a function called priming bolus which allows drugs to move quickly from the pump to the tip of the catheter to deliver medication while the patient is under medical supervision. According to the company, using the priming bolus may result in the patient’s drug mixing with sterile water or cerebrospinal fluid, which may led to dilution of the drug or an extra delivery of medication. This flaw could lead to an overdose or not a large enough dose of a drug being delivered.
The Food and Drug Administration and Medtronic announced a Class I recall of two types of the pumps last year following reports that the motor on the pumps failed when used with drugs not specifically approved for them, potentially leading to a return of symptoms and/or death. Both the SynchroMed II Implantable and SynchroMed EL Implantable infusion pumps were recalled at that time.
Class I recalls are the most serious type of recall. It is issued for products deemed to have a reasonable risk of serious adverse events or death with use. In 2011, the FDA issued two other Class I recalls on the pumps. One of the infusion pumps recalled that year had battery problems and the other was recalled because of “pocket fills” that occurred during pump refills.
The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a SynchroMed infusion pump, defective medical device, or have endured any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or visit us at www.messalaw.com to submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More