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 97.7 97.0 96.6 95.9 94.1 94.1 94.1    
#   1070 846 591 366 232 145 85 57    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1427
Cumulative Months of Follow-Up 48621
Number of Leads Active in Study 713
Information 40

Qualifying Complications

Extra Cardiac Stimulation 7
Failure to Capture 10
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 19
Other 1
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 39
Failure to Capture 39
Impedance Out of Range 6
Lead Dislodgement 140
Oversensing 2
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants112706
Estimated Active USA Implants65348
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution197955
Information

USA Returned Product Analysis

Conductor Fracture 16
Insulation Breach 67
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 19
Insulation Breach 71
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 August 3, 2014

www.medtronic.com/productperformance 326050