Medtronic has announced a second Class I recall this year for its SynchroMed II drug infusion implantable pump over concerns the batteries can suddenly fail. This one comes after a late-May report showed there were at least 55 cases of device failure.
SynchroMed includes a catheter and pump infusion system that is implanted to deliver drugs to a specific area of the body. There are currently around 140,000 of the drug pumps in use worldwide.
According to reports, the problem is that a “filmy substance” seems to be building up on the pump battery, which causes the device to suddenly shut down. All of the reported problems, but one, are in pumps with batteries manufactured before 2005.
The first recall was issued in February over “pocket fill.” Pocket fill occurs when drugs are injected into the tissue where the pump is implanted rather than at the appropriate site. This can cause a serious injury or even death due to overdose or underdose of the drug.
A Class I recall is the most serious type of recall there is and is reserved for those situations where there is a “reasonable probability of serious adverse consequences or death.”
Many painkillers used with pumps like this can have serious adverse side effects. Adding the threat of a defective pump only amplifies their danger.
If you or a loved one has become seriously ill due to a defective pain pump or from the painkiller within the pump, please contact an experienced personal injury attorney in your area today.