Medtronic CRM Product Performance Report

Sigma 300 DR SDR303, SDR306

Product Characteristics
US Market Release Aug-99   NBG Code DDD/RO
Registered US Implants 107,000   Serial Number Prefix PJD, PJE
Estimated Active US Implants 53,000   Estimated Longevity  
Normal Battery Depletions (US) 394      
Malfunctions (US) 76    
Therapy Function Not Compromised 5      
Electrical Component 4      
Possible Early Battery Depletion 1      
Therapy Function Compromised 71      
Electrical Component 6      
Electrical Interconnect 65   (28 malfunctions related to advisory)
Advisories 2005 Potential Separation of Interconnect Wires
Survival Estimate of Sigma 300 DR SDR303, SDR306 Pulse Generators