Medtronic CRM Product Performance Report

5026 CapSure

    Product Characteristics
US Market Release Feb-88   Serial Number Prefix RZ
Registered US Implants 7,400   Type and/or Fixation Transvenous, Vent., Tines
Estimated Active US Implants 1,100   Polarity Bipolar
Advisories None   Steroid Yes

 

Ventricular Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 60
Electrical Malfunction 7
Other 1
Number of Leads Enrolled in Study 168
Cumulative Months of Follow-Up 9,611
Number of Leads Active in Study 5
     
Qualifying Complications 4 Total  
Electrical Abandonment 1  
Failure to Capture 3  
     

Survival Estimate of 5026 CapSure Ventricular Placement Leads