A Drug Called Baclofen

Battery problems could plague more than 140,000 Medtronic Synchromed II implantable painkiller pumps in use around the world, according to a warning issued last week by the medical device manufacturer.

Medtronic Inc. issued a press release on July 8, indicating that it has received at least 55 reports of incidents where batteries in SynchroMed II Implantable Drug Infusion Pumps have failed prematurely.

The company admits in the press release that it has been aware of the problem since July 2009, when it sent a letter to physicians. However, Medtronic indicates that it does not plan to issue a SynchroMed II recall, since the infusion pumps are surgically implanted.

According to Medtronic, the battery failures occur due to the buildup of a film in the infusion pump battery. The sudden failure of the painkiller pumps may cause a patient to no longer receive medication, which can result in the return of pain symptoms and could also cause them to suffer drug withdrawal. In some cases, like with patients receiving intrathecal baclofen to treat multiple sclerosis, the withdrawal symptoms could be life-threatening.

There are about 140,000 SynchroMed II drug pumps in use worldwide, the company reports. The pumps are designed to have an 84-month lifespan, but the premature failures have occurred as early as 48 months, the company warned.

The Medtronic pain pumps have a built-in alarm that should sound if the device begins to fail. Medtronic posted a SynchroMed II pain pump product advisory that includes sound files so that those implanted with the pump can recognize it in case of pump failure. Medtronic is only recommending replacement of the battery in instances where the pumps have failed.

The warning comes just months after a SynchroMed infusion pump recall was issued in February due to a defective design that could lead to health care professionals accidentally forcing lethal amounts of painkilling drugs into patients while trying to refill the device. Medtronic reported then that there had been at least 351 reports of overdose incidents involving the SynchroMed infusion pump from May 1996 to September 2010. Eight people died and 270 required medical intervention due to a serious or life threatening injury. Another 58 events are known that did not cause serious injury and there were 15 events where Medtronic did not know the outcome.

Medtronic estimated, based on the reports, that about 1 in every 10,000 SynchroMed drug refill attempts by health care professionals result in what was called a “pocket fill,” which occurs when a physician mistakenly inject the drugs directly into the patient’s subcutaneous tissue. However, the company said the actual rate of occurrence could be much higher, because it is likely that the medical mistakes are under reported.

A new battery design has been put into place for future SynchroMed II pumps in Europe, Australia, New Zealand, Canada, Africa and India. Medtronic is still trying to obtain approval for the design for pumps sold in the United States.Click Here!