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 10 yr
% Survival 96.0 95.1 94.4 94.1 93.4 92.6 92.2 91.7 91.1 90.4
#   635 496 417 330 261 210 172 141 91 62

Product Surveillance Registry Results

Number of Leads Enrolled in Study 802
Cumulative Months of Follow-Up 39685
Number of Leads Active in Study 73
Information 46

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 17
Impedance Out of Range 2
Lead Dislodgement 14
Unspecified Clinical Failure 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 18
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 Implants100812
Estimated Active USA Implants23390
US Market Release2002-05-03
CE Approval Date2000-12-22
Estimated WW Distribution190360
Information

USA Returned Product Analysis

Conductor Fracture 80
Insulation Breach 29
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 87
Insulation Breach 29
Crimp/Weld/Bond 0
Other 33
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 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 11, 2019

www.medtronic.com/productperformance 651050