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 15 yr 16 yr 17 yr 18 yr at 222.0 mo    
% Survival 99.5 99.3 99.0 98.7 98.2 97.9 97.5 97.1 96.7 96.1 95.8 95.3 95.0 94.2 93.7 91.2 90.5 89.6 89.6    
#   3293 2896 2541 2248 2017 1773 1525 1364 1209 1019 812 585 378 240 159 133 112 82 67    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4553
Cumulative Months of Follow-Up 290162
Number of Leads Active in Study 703
Information 102

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 38
Failure to Capture 8
Failure to Sense 2
Impedance Out of Range 13
Insulation (not further defined) 6
Lead Dislodgement 5
Oversensing 21
Other 5
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 26
Extra Cardiac Stimulation 2
Failure to Capture 82
Failure to Sense 36
Impedance Out of Range 61
Insulation Breach 4
Lead Dislodgement 124
Oversensing 141
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release2001-11-12
CE Approval Date2001-10-04
Registered USA Implants375372
Estimated Active USA Implants126901
US Market Release2001-11-12
CE Approval Date2001-10-04
Estimated WW Distribution615906
Information

USA Returned Product Analysis

Conductor Fracture 1372
Insulation Breach 103
Crimp/Weld/Bond 4
Other 197
Information

WW Returned Product Analysis

Conductor Fracture 1706
Insulation Breach 134
Crimp/Weld/Bond 4
Other 239
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 May 10, 2023

www.medtronic.com/productperformance 926050