January 17, 2012
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Comments of the Patient, Consumer, and Public Health Coalition
on Proposed Rule: Cardiovascular Devices;
Reclassification of External Pacemaker Pulse Generator Devices
[Docket No. FDA-2011-N-0650]
As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.
We agree with the Cardiovascular Devices Panel recommendations from March 9, 1979 that “external pacemaker pulse generators be classified into class III because the device provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.”
We disagree with the three device manufacturers who recommended that external pacemaker pulse generators be reclassified to class II. In the “Summary of Data Upon Which the Reclassification Is Based” section in the Federal Register notice it states: “Several key performance standards have been developed and used to support marketing applications over the years, which address various aspects of design and performance and have been determined to be sufficient in the establishment of requirements for market entry.”2 If that is the case, why were there 1869 Manufacturer and User Facility Device Experience (MAUDE) adverse event reports on External Pacemaker Pulse Generator Devices (Product code DTE) for the year 2011 alone? A review of the MAUDE database for the last five years (1/01/2007 through 12/30/2011) shows at least 13 deaths associated with these devices; the deaths were reported in 26 separate MAUDE reports. It undermines the public health and the integrity of the CDRH regulatory standards when devices such as these, which are clearly life sustaining, could result in death when they fail. They would be misclassified as class II devices.
Additionally, the Federal Register notes that these devices pose “risks to health” including: a failure of the electronic circuitry, which can cause failure to pace the patient’s heart; improper pacing leading to high rate-electric failure, which can lead to arrhythmias or unwanted stimulation; and micro/macro shocks resulting in an arrhythmia or cardiac tissue damage.
In summary, there are three reasons to keep External Pacemaker Pulse Generator Devices as class III devices:
- They are life-sustaining devices;
- They have had numerous MAUDE adverse events reports, including deaths associated with the devices; and
- They pose significant “risks to health.”
For these reasons, the class II Special Controls Guidance Document: External Pacemaker Pulse Generator (Draft Guidance) does not provide reasonable assurance of their safety and effectiveness. To ensure public health and patient safety these devices must remain as class III, and they must go through the more stringent PMA process, which requires clinical trials and inspections.
American Medical Women’s Association
Community Access National Network
National Consumers League
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
National Women’s Health Network
Our Bodies Ourselves
For additional information, contact Paul Brown at firstname.lastname@example.org or (202) 223-4000
 Food and Drug Administration (October 17, 2011). Class II Special Controls Guidance Document: External Pacemaker Pulse Generator, Draft Guidance.
 Federal Register Volume 76 (October 17, 2011). Proposed rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices [Docket No. FDA-2011-N-0650].