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 at 102.0 mo  
% Survival 98.8 97.6 97.0 96.4 95.8 94.5 94.0 93.3 93.3  
#   1272 1002 753 571 375 220 146 92 71  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1557
Cumulative Months of Follow-Up 62800
Number of Leads Active in Study 650
Information 51

Qualifying Complications

Extra Cardiac Stimulation 9
Failure to Capture 13
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 25
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 48
Failure to Capture 42
Impedance Out of Range 7
Lead Dislodgement 148
Oversensing 2
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants114229
Estimated Active USA Implants55675
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution237547
Information

USA Returned Product Analysis

Conductor Fracture 20
Insulation Breach 84
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 23
Insulation Breach 88
Crimp/Weld/Bond 0
Other 19
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 April 14, 2016

www.medtronic.com/productperformance 426050