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 95.0 94.3 94.0 93.2 92.4 92.4 91.8 91.8 90.8
#   597 455 364 282 225 186 147 119 81 53

Product Surveillance Registry Results

Number of Leads Enrolled in Study 764
Cumulative Months of Follow-Up 35049
Number of Leads Active in Study 93
Information 41

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 9
Failure to Capture 14
Lead Dislodgement 13
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 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 Implants100749
Estimated Active USA Implants24952
US Market Release2002-05-03
CE Approval Date2000-12-22
Estimated WW Distribution190287
Information

USA Returned Product Analysis

Conductor Fracture 67
Insulation Breach 19
Crimp/Weld/Bond 0
Other 48
Information

WW Returned Product Analysis

Conductor Fracture 74
Insulation Breach 19
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 August 3, 2016

www.medtronic.com/productperformance 451050