|Medtronic is recalling some batches of its Syncra pacemakers.--Courtesy of Medtronic|
Australian regulators have issued a "hazard alert" warning that a manufacturing snafu may cause a version of Medtronic's ($MDT) Consulta pacemaker to take in body fluid and then malfunction. But another model has also displayed problems; the company says it has recalled affected batches of both, and it has also notified surgeons.
Regulators' concerns Down Under revolve around a manufacturing issue identified in a subset of Consulta cardiac resynchronization therapy pacemaker C3TR01 devices made between April 1 and May 13, 2013. The sealing might be compromised, they said, which would enable bodily fluid to leak inside and make the device malfunction, regulators said. So far, one Australian patient has had the device implanted. But regulators say they've had no reports of device failures or injuries. They've also contacted the surgeon who implanted the device to explain the issue, but advised routine follow-up care.
Medtronic spokeswoman Tracy McNulty told FierceMedicalDevices via email that the company recently alerted physicians concerning Consulta and its Syncra cardiac resynchronization therapy pacemakers, noting that 1% to 2% made between April 1 and May 13, 2013 "may have an issue that could affect device function."
She said that Medtronic retrieved all affected, nonimplanted devices made during the timeframe in order to reinspect them. Additionally, the company identified 44 devices from the affected lot as having been implanted in the U.S. But McNulty noted that "there have been no reported or confirmed device failures or patients injuries," and that "no other Medtronic device models are affected." Meanwhile, MassDevice notes that the FDA has slapped a Class II recall status on the effort.
Medtronic, after having consulted with the independent Physician Quality Panel, is asking physicians to talk to their patients and have them seek immediate care if they have a return of any bradycardia or heart-failure-related symptoms. Additionally, the company recommends that physicians continue routine follow-up care and also carefully assess individual patient circumstances if they are considering any sort of pacemaker replacement for patients with an affected implant.
This isn't Medtronic's only issue with safety in recent weeks. Just a few days ago, the FDA slapped a Class I recall status on a part used with Medtronic's Paradigm insulin pumps, warning that it could lead to the delivery of too much or too little insulin.