6942 Sprint
Defibrillation
6942 Sprint
ALL
Information

Device Survival Probability

6942_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 99.1 99.1 98.1 97.5 96.7 96.7 96.7 96.7 96.7  
#   301 235 179 139 113 96 74 63 51  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 357
Cumulative Months of Follow-Up 18886
Number of Leads Active in Study 30
Information 7

Qualifying Complications

Conductor Fracture 1
Failure to Sense 1
Lead Dislodgement 1
Oversensing 3
Unspecified Clinical Failure 1
Information

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 4
Impedance Out of Range 2
Lead Dislodgement 1
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1997-07-18
CE Approval Date
Registered USA Implants17684
Estimated Active USA Implants5180
US Market Release1997-07-18
CE Approval Date
Estimated WW Distribution22986
Information

USA Returned Product Analysis

Conductor Fracture 15
Insulation Breach 23
Crimp/Weld/Bond 1
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 22
Insulation Breach 26
Crimp/Weld/Bond 1
Other 8
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Tines
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Integrated Bipolar/Two Coils
More
Serial Number Prefix TCB
Lead Body Diameter 7.8 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050