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 at 126.0 mo                    
% Survival 98.6 97.4 96.7 96.2 95.6 94.4 94.2 93.1 93.1 92.6 91.7                    
#   1346 1121 918 746 555 420 256 163 98 66 53                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1616
Cumulative Months of Follow-Up 78178
Number of Leads Active in Study 438
Information 62

Qualifying Complications

Conductor Fracture 2
Extra Cardiac Stimulation 11
Failure to Capture 18
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 28
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 49
Failure to Capture 42
Impedance Out of Range 8
Lead Dislodgement 151
Oversensing 2
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants114945
Estimated Active USA Implants53233
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution240338
Information

USA Returned Product Analysis

Conductor Fracture 29
Insulation Breach 119
Crimp/Weld/Bond 0
Other 7
Information

WW Returned Product Analysis

Conductor Fracture 35
Insulation Breach 124
Crimp/Weld/Bond 0
Other 17
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 January 31, 2018

www.medtronic.com/productperformance 601051