Medtronic catheter faces class 1 recall : Drug-pump part linked to one death

-TwinCities.com

09/27/2008- The U.S. Food and Drug Administration has determined problems with a Medtronic catheter used in many of the company's implantable drug pumps should be considered a class 1 recall — the most serious type.

The problem has been linked to one death, the Fridley-based company said Friday, adding it sent physicians a safety alert letter about the issue in June.

Medtronic has sold some 25,000 catheters of the type discussed in the recall, said spokeswoman Cindy Resman.

Medtronic's drug pumps are implanted in the abdomen and deliver medication through a catheter to the intrathecal space in the spine, the area that surrounds the spinal cord.

In 83 cases reported to date, a particular type of catheter used with the drug pump has become blocked or disconnected, resulting in patients not receiving the drugs they need.

In one case, a patient died from acute withdrawal of baclofen, a drug that can be administered by the pump to relax muscles in patients with spasticity. A second death was reported after device replacement, although health care workers involved did not consider the death to be related to the device, Medtronic said.

Neither Medtronic's letter to physicians in June nor the FDA's classification Friday called on patients to have devices removed, and hospitals and doctors are not being asked to return unused products.

The company has issued recommendations on how to prevent and detect the problem. Patients who experience the catheter problems

described in the recall will require a surgical procedure for correction, Medtronic said.

Medtronic's investigation of the 83 patient reports found a problem with the connection between the catheters and the catheter ports on the drug pumps. Improper attachment can result in catheter connector damage, leaks at the connection site or catheter disconnection some time after implant, the company said.

In March, Medtronic said the FDA had determined that a January letter to doctors about a different kind of problem with the same drug-pump product also constituted a class 1 recall. In that case, Medtronic had alerted doctors to an increase in reported cases of inflammatory mass associated with intrathecal drug delivery.