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
#   639 496 419 332 264 216 173 145 95 63

Product Surveillance Registry Results

Number of Leads Enrolled in Study 802
Cumulative Months of Follow-Up 40068
Number of Leads Active in Study 65
Information 47

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 18
Impedance Out of Range 2
Lead Dislodgement 14
Other 0
Unspecified Clinical Failure 3
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 Implants100363
Estimated Active USA Implants22002
US Market Release2002-05-03
CE Approval Date2000-12-22
Estimated WW Distribution190360
Information

USA Returned Product Analysis

Conductor Fracture 83
Insulation Breach 29
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 90
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
More
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 November 8, 2019

www.medtronic.com/productperformance 726050