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 12 yr 13 yr                
% Survival 98.6 97.4 96.7 96.1 95.6 94.4 94.3 93.4 93.4 93.1 92.6 92.6 92.6                
#   1239 1047 899 770 696 611 483 377 298 219 157 93 64                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1647
Cumulative Months of Follow-Up 92278
Number of Leads Active in Study 272
Information 67

Qualifying Complications

Conductor Fracture 2
Extra Cardiac Stimulation 11
Failure to Capture 21
Impedance Out of Range 0
Insulation (ESC) 1
Insulation (not further defined) 2
Lead Dislodgement 30
Other 0
Information

Customer Communications For This Model

  • There are no communications 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 9
Lead Dislodgement 153
Oversensing 2
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release2004-08-24
CE Approval Date2003-07-14
Registered USA Implants115020
Estimated Active USA Implants30309
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution244205
Information

USA Returned Product Analysis

Conductor Fracture 46
Insulation Breach 161
Crimp/Weld/Bond 0
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 52
Insulation Breach 167
Crimp/Weld/Bond 0
Other 4
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 October 11, 2021

www.medtronic.com/productperformance 826050