4194 Attain OTW
Left-Heart Pacing
4194 Attain OTW
ALL
Information

Device Survival Probability


4194_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr      
% Survival 98.6 97.3 96.8 96.3 95.5 93.2 93.2      
#   1010 767 494 308 189 132 64      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1387
Cumulative Months of Follow-Up 43457
Number of Leads Active in Study 763
Information 40

Qualifying Complications

Extra Cardiac Stimulation 8
Failure to Capture 12
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 17
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 32
Failure to Capture 36
Impedance Out of Range 6
Lead Dislodgement 130
Oversensing 2
Unspecified Clinical Failure 5
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants111118
Estimated Active USA Implants64753
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution194669
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 59
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 15
Insulation Breach 62
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 January 31, 2014

www.medtronic.com/productperformance 301050