Medtronic CRM Product Performance Report

4074 CapSure Sense

    Product Characteristics
US Market Release Jun-02   Serial Number Prefix BBD
Registered US Implants 63,000   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 45,200   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 13
Electrical Malfunction 8
Other 1
Number of Leads Enrolled in Study 622
Cumulative Months of Follow-Up 24,361
Number of Leads Active in Study 516
     
Qualifying Complications 5 Total  
Failure to Capture 1  
Failure to Sense 1  
Impedance Out of Range 1  
Lead Dislodgement 2  

Survival Estimate of 4074 CapSure Sense Ventricular Placement Leads