Medtronic Dual-Chamber External Temporary Pulse Generators Model 5388 - Class 2 recall
MedSun: Newsletter #56, January 2011

FDA Medical Device Recalls

A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down at a later time while in use. Medtronic issued an Important Medical Device Correction letters, dated October 2010 and November 2010 to hospital's biomedical engineering department. Medtronic will contact the hospitals to return affected product for servicing. MedSun has received reports with this device. To read the events, please see the links provided in Additional Information below.

Additional Information:

FDA Medical Device Recalls. Medtronic Dual-Chamber External Temporary Pulse Generators Model 5388 – Class 2 recall. November 22, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95390

Related MedSun report. Medtronic Dual Chamber Temporary Pacemaker. February 10, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D7%3E%27%5FP%20%0A

Related MedSun report. Medtronic Temporary Pacemaker. March 25, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D7%3A%26%5F8%20%0A


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