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  
% Survival 98.7 97.5 97.0 96.4 95.9 94.4 94.1 93.5 93.5  
#   1301 1048 800 601 432 260 167 106 65  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1574
Cumulative Months of Follow-Up 66770
Number of Leads Active in Study 603
Information 53

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 13
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 26
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 8
Lead Dislodgement 148
Oversensing 2
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants114264
Estimated Active USA Implants55225
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution238269
Information

USA Returned Product Analysis

Conductor Fracture 22
Insulation Breach 92
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 25
Insulation Breach 96
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 August 3, 2016

www.medtronic.com/productperformance 451050