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 8 yr 9 yr 10 yr 11 yr                    
% Survival 98.6 97.4 96.7 96.1 95.6 94.4 94.2 93.4 93.4 93.0 92.4                    
#   1377 1155 969 803 667 496 340 245 153 99 61                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1640
Cumulative Months of Follow-Up 86600
Number of Leads Active in Study 333
Information 65

Qualifying Complications

Conductor Fracture 2
Extra Cardiac Stimulation 11
Failure to Capture 19
Impedance Out of Range 0
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 30
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 2
Extra Cardiac Stimulation 49
Failure to Capture 42
Impedance Out of Range 9
Lead Dislodgement 151
Oversensing 2
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants114795
Estimated Active USA Implants50180
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution240396
Information

USA Returned Product Analysis

Conductor Fracture 37
Insulation Breach 140
Crimp/Weld/Bond 0
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 43
Insulation Breach 145
Crimp/Weld/Bond 0
Other 3
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation 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 November 8, 2019

www.medtronic.com/productperformance 726050