Medical Technology: For Some Cardiac Pacemaker Leads, the Public Health Risks Are Still High: Pemd-92-20 (Paperback) (ISBN-13: 9781289101923)

Pursuant to a congressional request, GAO investigated: (1) the Food and Drug Administration's (FDA) actions preceding the recall of a cardiac pacemaker lead; and (2) continuing threats to public health posed by 14 other pacemaker lead models that had the same technological characteristics as the recalled lead.

GAO found that: (1) FDA recalled the lead model after receiving estimates of the numbers of deaths that could occur as a result of lead failure, but did not request that the manufacturer provide its clinical failure rate data; (2) FDA did not collect or request appropriate data to evaluate risks posed by polyurethane insulation in the leads still on the market; (3) FDA erroneously believed that it lacked authority to require manufacturers to collect such data; (4) before product recall, the manufacturer notified physicians of the lead's potential for failure, but marketed a modified model without notifying FDA; (5) FDA failure to fully implement legislative requirements regarding pacemaker registry limits the usefulness of the registry, and FDA has not validated information or assessed the quality of data; (6) FDA failure to collect or require the collection of clinical data during postmarket surveillance delays the product recall process and extends the period of time that patients may be exposed to a hazardous product; and (7) since most pacemaker recipients are elderly and eligible for Medicare coverage, defective leads can pose a considerable cost to the government.

Author: U. S. Government Accountability Office (
ISBN-10: 1289101922
ISBN-13: 9781289101923
Publisher: Bibliogov
Language: English
Published: 06/27/2013
Pages: 60
Format: Paperback
Weight: 0.28lbs
Size: 9.69h x 7.44w x 0.12d