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

Device Survival Probability

4194_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr
% Survival 98.6 97.4 96.7 96.2 95.6 94.5 94.2 93.0 93.0 92.4
#   1337 1105 897 690 532 384 230 146 85 59

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1606
Cumulative Months of Follow-Up 75231
Number of Leads Active in Study 483
Information 61

Qualifying Complications

Conductor Fracture 2
Extra Cardiac Stimulation 11
Failure to Capture 17
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 48
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 Implants114891
Estimated Active USA Implants53528
US Market Release2004-08-24
CE Approval Date2003-07-14
Estimated WW Distribution240082
Information

USA Returned Product Analysis

Conductor Fracture 27
Insulation Breach 110
Crimp/Weld/Bond 0
Other 7
Information

WW Returned Product Analysis

Conductor Fracture 32
Insulation Breach 114
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
Hide this content

Data as of July 31, 2017

www.medtronic.com/productperformance 501050