October 25, 2011
[Docket No. FDA-2011-N-0522]
The listed patient, consumer, and public health organizations below strongly support the FDA’s proposal to require the filing of a premarket approval application (PMA) for the implantable pacemaker pulse generator, a class III pre-amendments device.
We agree with the January 2009 GAO report, and the recent Institute of Medicine report on the 510(k) process’s recommendations 7-8, which state that the FDA should promptly call for PMA applications or reclassify the Class III devices that are still cleared by the 510(k) process. The implantable pacemaker pulse generator is one of those Class III devices alluded to by GAO and IOM.
The Cardiovascular Devices Advisory Panel determined that this device is “implanted and life-supporting and presents a potential unreasonable risk of illness or injury” and so should remain a class III device and should not be reclassified into class II or I. They also stated “that premarket approval [PMA] was necessary to assure the safety and effectiveness of the device. FDA continues to agree with the panel’s recommendation.”
Given the safety concerns with this device, we strongly support the Panel and the FDA’s conclusions. Eight significant risks to health are cited in the July 27, 2011 Federal Register notice concerning this device. Malfunctions of this device could result in “a dangerously slow heart rate…which could result in weakness, dizziness, fainting or even death.” Other complications include shortness of breath, chest pain, tissue damage, palpitations, fatigue, infection, hematoma and body rejections phenomena.
In 2009, the National Research Center for Women & Families examined the MAUDE database and found 88 deaths associated with the Product code DXY (the code for the implantable pacemaker pulse generator). All of these devices were cleared by the 510(k) process. If these devices had been subject to the more rigorous PMA process, which requires valid scientific evidence (well-controlled investigations, objective trials and reports of significant human experience with a marketed device as well as pre-market inspections), we think some of these deaths could have been avoided. This is an example of why the FDA should issue the final rule as quickly as possible and require the companies that make implantable pacemaker pulse generator devices to submit a PMA application as soon as the law allows. We understand that to be within 90 days of the final rule.
CANN-Community Access National Network
Center for Medical Consumers
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
Our Bodies Ourselves
The TMJ Association
For more information, please contact Paul Brown at email@example.com.