Take the Lead on Safety with Temporary Cardiac Pacing
MedSun: Newsletter #47, April 2010

FDA Medical Device Safety

Temporary cardiac pacing is indicated for emergency treatment of some bradyarrhythmias and tachyarrhythmias, and prophylactically for patients at risk for brady - arrhythmias during cardiovascular surgery. Pacing lead wire disconnections, fractures, and misconnections are some of the problems known to be associated with temporary transvenous pacing leads. The following case examples were reported to the FDA through the medical device reporting program.

Additional Information:

FDA Medical Device Safety. Take the Lead on Safety with Temporary Cardiac Pacing. Dwyer, Diane; Bauer, Kelly. March 9, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm203731.htm

MedSun Report. September 26, 2009. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D3%3F%27%2FH%20%0A

MedSun Report. August 13, 2009. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2DO%3C%26%3F%5C%20%0A&CFID=35984629&CFTOKEN=e548de388c794210-9AE