This article has been updated with comments from Medtronic.
In a global urgent field notice to healthcare providers, the company said it received complaints about the pumps’ motors stalling permanently. A company investigation determined the presence of a foreign particle inside the motor assembly “due to an isolated manufacturing issue,” Medtronic told MassDevice in an email. The company said it has identified the source of the foreign particle and eliminated it.
The voluntary recall affects Models 8637-20 and 8637-40 manufactured between May 4, 2018, and April 5, 2019. A permanent motor stall will halt drug infusion therapy and could cause patient symptoms to return or lead to withdrawal symptoms, according to Medtronic. For example, patients receiving intrathecal baclofen could develop baclofen withdrawal syndrome, which can lead to a life-threatening condition.
Medtronic said that as of Sept. 30, it had received five reports of early permanent motor stall due to the presence of a foreign particle. Two were identified prior to implant and the rest within five months of implant. In each case, the pump alarm functioned properly, the company added. Of the three patients who had the devices explanted, one required hospitalization to manage withdrawal symptoms, Medtronic said.
The implantable pumps are used primarily to treat chronic and cancer-related pain and to provide long-term management of severe spasticity. They have been the subject of hundreds of lawsuits. In September, the company reportedly agreed to create a settlement fund worth some $35 million to compensate about 500 people who claim they were harmed by it because of a separate issue.
Medtronic said customers who have potentially affected pumps in their inventory have been notified and asked to return them to Medtronic. The company said it is not recommending prophylactic replacement of potentially affected SynchroMed II pumps. The FDA has not classified the recall.
“At Medtronic, patient safety is our top priority,” the company said. “We take quality concerns seriously, investigate adverse events thoroughly, and proactively communicate with healthcare practitioners, patients, and regulatory agencies.”