The FDA has issued a Class I recall for Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps. The pumps are used to treat primary or metazoic cancer, chronic pain, and severe spasticity by delivering prescribed drugs to a specific site in the body. Flaws in the pump may lead to too much or too little medication being delivered. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Fourteen patients have died since 1996 while using the SynchroMed System. Eleven patients died due to inadvertent injection of a drug into their subcutaneous tissue instead of into the pump. Two patients died from a blockage and one died from an electrical short. Patients may also been harmed by the dilution or extra delivery of medication.
[1] FDA Recall "Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Feed Through Failure" (June 3, 2013).
[2] Cortez, M. "Medtronic Recalls Infusion Pump Linked to 14 Deaths," Bloomberg News (June 27, 2013).
Fourteen patients have died since 1996 while using the SynchroMed System. Eleven patients died due to inadvertent injection of a drug into their subcutaneous tissue instead of into the pump. Two patients died from a blockage and one died from an electrical short. Patients may also been harmed by the dilution or extra delivery of medication.
[1] FDA Recall "Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Feed Through Failure" (June 3, 2013).
[2] Cortez, M. "Medtronic Recalls Infusion Pump Linked to 14 Deaths," Bloomberg News (June 27, 2013).
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