Medtronic Sprint Quattro Secure S, model 6935 - 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. 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 event, please see the link provided in Additional Information below.

Additional Information:

FDA Medical Device Recalls. Medtronic Sprint Quattro Secure S, model 6935 – Class 2 recall. November 26, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95370

Related MedSun report. Sprint Quattro Secure Sprint Fidelis. May 9, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%5DS%3F%27%3F%3C%20%0A


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