Medtronic Sprint Quattro Secure S, model 6947 - Class 2 Recall
MedSun: Newsletter #56, January 2011

FDA Medical Device Recalls

Over-retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads. Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. 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 Sprint Quattro Secure S, model 6947 – Class 2 recall. November 26, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95371

Related MedSun report. Sprint Quattro Secure CapSureFix Novus. July 28, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%5DS6%25O%3C%20%0A

Related MedSun report. Sprint Quattro Secure. December 19, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D3%3A%25O8%20%0A

Related MedSun report. Sprint Quattro Secure. June 12, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2DK8%26OT%20%0A


MedSun Newsletters are available at www.fda.gov/cdrh/medsun