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  
% Survival 95.8 94.8 94.0 93.8 93.4 92.4 92.4 91.7 91.7  
#   547 413 341 268 208 173 139 105 68  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 730
Cumulative Months of Follow-Up 31719
Number of Leads Active in Study 115
Information 41

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 13
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 17
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 Implants100767
Estimated Active USA Implants32414
US Market Release2002-05-03
CE Approval Date2000-12-22
Estimated WW Distribution175390
Information

USA Returned Product Analysis

Conductor Fracture 58
Insulation Breach 12
Crimp/Weld/Bond 0
Other 48
Information

WW Returned Product Analysis

Conductor Fracture 64
Insulation Breach 12
Crimp/Weld/Bond 0
Other 102
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 August 3, 2014

www.medtronic.com/productperformance 326050