REVISED Recommendations for Guidant Defibrillator

• Schedule a patient follow-up visit
  
  • As soon as possible for patients reprogrammed to 0% according to our June 17th recommendation, or any patient with Atrial Episode Data Storage programmed to less than 20%
    
  • Per normal scheduling if Atrial Episode Data Storage is at the nominal of 50% or is programmed to 20% or more
    
  
  
• At this follow-up visit:
  
  • Verify normal device function using routine clinical follow-up procedures
    
  • Program Atrial Episode Data Storage to 20% 3) Review the rate of occurrence estimates in Table 1 to evaluate the additional risk reduction benefit of programming ATP therapy OFF
    
  
  

Table 1 below quantifies the probability of latching associated with each of these programming

Important notes:

1. Atrial Episode Data Storage should not be programmed to 0% if the
   previously stored atrial episode data.
   
2. For some patients for whom atrial episode data has not been previously
   to 0% may afford additional risk reduction. Contact Technical Services
   information before programming Atrial Episode Data Storage to 0%.
   

Programming options	Probability of latching per month	Probability of latching per 6 months	Probability of latching with continuous ATP therapy per 6 months
If atrial episodes have been previously stored and Atrial Tachy Episode Data Storage is programmed to 0% [Not recommended]	0.086% (1 per 1,160)	0.52% (1 per 192)	0.027% (1 per 3,700)
At Atrial Tachy Episode Data Storage of 50% (nominal)	0.00083% (1 per 120,000)	0.005% (1 per 20,000)	0.000265% (1 per 377,000)
If atrial episodes have been previously stored, program Atrial Tachy Episode Data Storage to 20%	0.00043% (1 per 232,000)	0.0026% (1 per 38,500)	0.00014% (1 per 714,000)
Program all ATP therapies to OFF	No change	No change	Zero
(3) Following implementation of a software solution in early Q405(2)	Zero Return to normal programming	Zero Return to normal programming	Zero Return to normal programming

(1) Probabilities are current as of July 21, 2005. (2) While the probabilities are stated over a six month time frame, a software solution may be available in early Q405, pending FDA approval. (3) Although functional latching may still occur, it will not result in continuous ATP therapy.