NEW YORK (Reuters) - Medtronic Inc said on Wednesday it alerted physicians last month of potential danger from misuse of its implantable infusion pumps that led to 8 deaths since 1996.
The U.S. Food and Drug Administration on its website classified the issue as a Class I recall, which involves the potential of serious harm or death to patients.
But Medtronic is not actually recalling its SynchroMed II and SynchroMed EL pumps as the problem is related to improper use rather than a defect in the devices.
The infusion pumps, which are implanted into the abdomen, are used for constant delivery of drugs or fluids to patients.
Problems arise when refills of the drugs are accidentally injected directly into the patients all at once rather than into the pump for gradual administration of the medication.
Between May 1996 and September 2010, including an earlier version of the pumps that is no longer sold, there were reports of 8 deaths and 270 events requiring medical intervention, Medtronic said.
The FDA said doctors were alerted to the need to check needle placement within the pump during the drug-refill procedure to make sure fluids are deposited in the pump reservoir and not directly into patients.
Medtronic issued an urgent letter to healthcare providers in mid-January about the problem with the pumps, which are primarily used to treat chronic pain and severe spasticity.
“We informed physicians of our awareness of this issue, which in approximately .01 percent of refills there were reports of adverse events,” Medtronic spokeswoman Cindy Resman said.
“Our goals with this communication was to provide additional information related to specific visual and tactile assessments to ensure the refill is done successfully,” Resman added.
Reporting by Bill Berkrot and Ransdell Pierson; Editing by Tim Dobbyn