APPENDIX III

An Illustration of Impact of Current Patient Management Recommendations for a Hypothetical Clinic of 1,000 Sprint Fidelis Lead Patients over the Next 12 Months

1,000 X 0.01² X 0.9 X 0.51 = 4.6³

1,000 patient sample

Hypothetical sample of 1,000 patients with the same age distribution and implant length distribution as the overall Sprint Fidelis lead population.1

Fracture rate over the next 12 months

1.0% is the fracture rate expected over the next 12 months. This is calculated by projecting the risk of fracture on the lead survival curve for this population.

Anode and cathode
conductor fractures

Approximately 90% of the fractures observed are in the anode and cathode conductors (pace/sense circuit).

Fractures with short notice or no notice

The patient recommendations will provide 2 or more days of advance notice to 49% of patients. The remaining 51% of patients will receive less than 2 days of advance notice or no advance notice.

Number of patients

Over the next 12 months using the hypothetical sample of 1,000 patients, 9 will have an anode or cathode fracture.
Of those, 4.6 patients will have less than 2 days of advance notice or no advance notice. This is 0.46% of the sample.
4.4 patients will have 2 or more days of advance notice. This is 0.44% of the sample.

 


References

1

The median patient age is 67 (age at time of lead implant) and the median implant time is 20.5 months.

2

This represents an estimate of the average rate of fracture over the next 12 months based on currently available data.

3

Medtronic recognizes that not all patients will hear the alert when it is triggered. The new software described in this performance update is intended to enhance the patient alert and increase the likelihood that fractures will be detected prior to inappropriate therapy.