4193 Attain OTW
Left-Heart Pacing
4193 Attain OTW
ALL
Information

Device Survival Probability

4193_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo
% Survival 95.9 94.9 94.1 93.8 93.1 92.2 92.2 91.6 91.6 90.6
#   593 441 357 280 223 183 146 118 77 61

Product Surveillance Registry Results

Number of Leads Enrolled in Study 761
Cumulative Months of Follow-Up 34344
Number of Leads Active in Study 103
Information 42

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 14
Lead Dislodgement 14
Other 1
Unspecified Clinical Failure 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 19
Failure to Capture 11
Lead Dislodgement 45
Oversensing 1
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2002-05-03
CE Approval Date2000-12-22
Registered USA Implants100816
Estimated Active USA Implants25264
US Market Release2002-05-03
CE Approval Date2000-12-22
Estimated WW Distribution190292
Information

USA Returned Product Analysis

Conductor Fracture 66
Insulation Breach 15
Crimp/Weld/Bond 0
Other 48
Information

WW Returned Product Analysis

Conductor Fracture 73
Insulation Breach 15
Crimp/Weld/Bond 0
Other 101
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 Unipolar
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Serial Number Prefix BAA
Lead Body Diameter 4.0 FR
Insulation Polyurethane (55D)
Pace/Sense Connector Style IS-1 UNI
High Voltage Connector n/a
Steroid Yes
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Data as of April 14, 2016

www.medtronic.com/productperformance 426050