Medtronic CRM Product Performance Report

4024 CapSure SP

    Product Characteristics
US Market Release Oct-91   Serial Number Prefix LAJ
Registered US Implants 222,100   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 56,100   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 264
Electrical Malfunction 135
Other 34
Number of Leads Enrolled in Study 1,214
Cumulative Months of Follow-Up 52,403
Number of Leads Active in Study 23
     
Qualifying Complications 3 Total  
Failure to Capture 3  
     

Survival Estimate of 4024 CapSure SP Ventricular Placement Leads