FDA Issues Warning About Design Flaw in Medtronic Drug Pump

A serious design defect has shown up in The Medtronic drug pump intended to deliver drugs to victims of chronic pain and spasms.

This device delivers drugs directly into the spinal fluid as a way to treat chronic pain and spasticity.

The malfunction in the pump has caused interruptions in the delivery of the drugs which has prompted the FDA to issue a class-one recall of this product.

SynchroMed II implantable pump models 8637-20 and 8637-40, distributed between 2004 and 2011 have faced the recall.

Patients have been advised to consult their doctor if they experience any symptoms or if the alarm inside the device goes off.



Source: Medindia