4194 Attain OTW
Left-Heart Pacing
4194 Attain OTW
ALL
Information

Device Survival Probability

4194_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 90.0 mo    
% Survival 98.8 97.6 96.9 96.5 96.0 94.4 94.4 94.4    
#   1138 866 657 405 262 164 98 73    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1468
Cumulative Months of Follow-Up 52175
Number of Leads Active in Study 686
Information 43

Qualifying Complications

Extra Cardiac Stimulation 8
Failure to Capture 11
Impedance Out of Range 0
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 21
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 2
Extra Cardiac Stimulation 41
Failure to Capture 39
Impedance Out of Range 6
Lead Dislodgement 144
Oversensing 2
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants113369
Estimated Active USA Implants63630
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution199696
Information

USA Returned Product Analysis

Conductor Fracture 18
Insulation Breach 68
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 21
Insulation Breach 72
Crimp/Weld/Bond 0
Other 21
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Distal Double Curve
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LFG
Lead Body Diameter 6.0 FR
Insulation Polyurethane (55D) outer; silicone inner
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of February 9, 2015

www.medtronic.com/productperformance 351052