Medtronic Recalls Implantable Drug Pumps – 14 Deaths
Medtronic has issued a recall of its SynchroMed Implantable Infusion System which have resulted in 14 confirmed patient deaths between May 1996 and April 2013. The U.S. Food and Drug Administration classified the recall as a Class 1 recall which means “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The FDA has issued multiple statements and warnings regarding Medtronic SynchroMed drug pumps in the past.
SynchroMed's Unintended Drug Delivery – Priming Bolus Function
- The priming bolus function is used to quickly move medication though the pump to the catheter for faster delivery of medication to the spinal cord.
- Medtronic found that upon use of the priming bolus function, the medications could mix with sterile water and spinal fluids already in the catheter.
- This brings about risks of unintended drug delivery, diluted drug delivery, overdose and underdose.
- 11 patient deaths have been attributed to unintended drug delivery.
SynchroMed- Catheter Blockage
- A catheter used in a previous design carried risk of blockage, stopping the medication from being delivered to the patient.
- Medtronic had to redesign original catheter to reduce catheter blockage.
- 2 patient deaths have been attributed to catheter blockage.
SynchroMed- Potential Electrical Short Circuit
- Shorts within the pump may lead to the pump motor stalling, no longer allowing the pump to deliver medication.
- This can lead to the return of the patient’s underlying symptoms or to drug withdrawals.
- 1 patient death has been attributed to electric short circuit.
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