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APPENDIX IV

Probability that a Sprint Fidelis Lead Fracture may Result in Critical Injury from Loss of Pacing

This appendix calculates the critical injury risk for a pacemaker dependent patient programmed according to Medtronic’s recommendations who experiences a Sprint Fidelis lead fracture. Based on currently available data, we estimate the critical injury risk to be less than 0.1% for the majority of pacemaker dependent patients through 30 months of implant time.

Probability of Sprint Fidelis lead fracture through 30 months of implant time:
= 2.5%

    
       

Proportion of fractures occurring in the anode or cathode conductors:
= 90%

    
       

Approximate percentage of patients without alert triggered prior to event:
= 51%*

    
       

Probability of an anode or cathode fracture resulting in a loss of pacing output:
= 6.9%

    
       

Overall probability of a Sprint Fidelis lead fracture occurring and resulting in a loss of pacing output
= 0.08%

    
       

Not all pacemaker dependent patients experience critical injury with loss of pacing. We estimate this percentage to be 15%.

  

The resulting probability of a Sprint Fidelis lead fracture at 30 months resulting in critical injury due to loss of pacing is estimated to be approximately:
0.012%
(Conservatively, we conclude risk to be <0.1%)
 

*This percentage may vary by implanted device.

Last updated: 22 Sep 2010

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