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 95.7 94.6 94.3 93.4 93.4 92.9 92.1                    
#   1360 1136 947 776 604 442 298 190 117 71 59                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1625
Cumulative Months of Follow-Up 81517
Number of Leads Active in Study 381
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 Implants114965
Estimated Active USA Implants52854
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution240389
Information

USA Returned Product Analysis

Conductor Fracture 31
Insulation Breach 122
Crimp/Weld/Bond 0
Other 7
Information

WW Returned Product Analysis

Conductor Fracture 37
Insulation Breach 127
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 October 12, 2018

www.medtronic.com/productperformance 626050