6947 Sprint Quattro Secure
Defibrillation
6947 Sprint Quattro Secure
ALL
Information

Device Survival Probability

6947_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr 14 yr at 174.0 mo            
% Survival 99.5 99.3 99.0 98.7 98.2 97.9 97.6 97.1 96.6 95.9 95.4 94.7 94.7 94.1 93.4            
#   3834 3304 2797 2353 1953 1561 1157 893 614 323 174 110 90 70 60            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4445
Cumulative Months of Follow-Up 257153
Number of Leads Active in Study 1038
Information 88

Qualifying Complications

Conductor Fracture 31
Failure to Capture 7
Failure to Sense 2
Impedance Out of Range 12
Insulation (not further defined) 5
Lead Dislodgement 5
Oversensing 19
Other 4
Unspecified Clinical Failure 3
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 29
Conductor Fracture 25
Extra Cardiac Stimulation 2
Failure to Capture 81
Failure to Sense 34
Impedance Out of Range 59
Insulation Breach 4
Lead Dislodgement 122
Oversensing 140
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants374976
Estimated Active USA Implants188756
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution603649
Information

USA Returned Product Analysis

Conductor Fracture 1195
Insulation Breach 97
Crimp/Weld/Bond 4
Other 189
Information

WW Returned Product Analysis

Conductor Fracture 1506
Insulation Breach 125
Crimp/Weld/Bond 4
Other 233
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Active Screw In
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar/Two Coils
More
Serial Number Prefix TDG
Lead Body Diameter 8.6 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of April 10, 2020

www.medtronic.com/productperformance 751050