Medtronic initiates Class I recall of implantable infusion pumps
Potential for reduced battery performance in the SynchroMed II Implantable Infusion Pump has prompted a Class I voluntary recall of the device by Minneapolis-based manufacturer Medtronic.
Medtronic began notifying physicians of the problem with an Urgent Medical Device Correction letter on July 5, according to the FDA, and a news release was issued on July 8.
The problem is related to the formation of a film within the pump battery, according to the company, and could lead to the loss of therapy and a return to underlying symptoms or withdrawal symptoms.
Patients receiving intrathecal baclofen therapy for severe spasticity, for example, could be at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively, according to the FDA.
The SynchroMed II Implantable Infusion Pump, which was distributed between May 2004 and July 2011, is indicated for patient therapies that involve chronic infusion of drugs or fluids. The product is indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity. It can also be used for the delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer.
Medtronic’s correction letter can be found here. Click here for the FDA release.
Medtronic began notifying physicians of the problem with an Urgent Medical Device Correction letter on July 5, according to the FDA, and a news release was issued on July 8.
The problem is related to the formation of a film within the pump battery, according to the company, and could lead to the loss of therapy and a return to underlying symptoms or withdrawal symptoms.
Patients receiving intrathecal baclofen therapy for severe spasticity, for example, could be at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively, according to the FDA.
The SynchroMed II Implantable Infusion Pump, which was distributed between May 2004 and July 2011, is indicated for patient therapies that involve chronic infusion of drugs or fluids. The product is indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity. It can also be used for the delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer.
Medtronic’s correction letter can be found here. Click here for the FDA release.