Table 1.

October 2007 decisions and recommendations regarding the management of Sprint Fidelis leads

Decisions and recommendations from the manufacturer	Additional recommendations from AFSSAPS
Suspension of commercial distribution	Reminder to the physicians to inform the lead recipients, in compliance with article L.1111-2 of the Public Health Code
Recall of non-implanted leads	Schedule an ambulatory visit within a maximum of 3 months, followed by the 3-month follow-up schedule recommended by the manufacturer
It would be inappropriate to extract or replace the lead prophylactically (statement by an independent physician review committee). This recommendation is not applicable to patients presenting with special circumstances. The risk associated with an overt lead fracture must be weighed against the risk associated with extraction of the lead or its replacement	At each routine follow-up: Verify that the ICD software has been updated and, for recipients of ICD not manufactured by Medtronic, verify that the device includes similar software capable of triggering an alarm in case of lead fracture.
Follow-ups should include: Specific device programming and update of the ICD software in order to increase the likelihood of detecting a lead fracture and to lower the risk of inappropriate therapy delivery.

AFSSAPS, the legal authority of the French Agency for the Sanitary Safety of Health Products; ICD, implantable cardioverter–defibrillator.