4196 Attain Ability
Left-Heart Pacing
4196 Attain Ability
ALL
Information

Device Survival Probability

4196_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 98.0 97.3 96.5 95.9 95.4 94.6 94.2 94.2    
#   1883 1474 1148 890 683 482 313 120    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2276
Cumulative Months of Follow-Up 97161
Number of Leads Active in Study 481
Information 82

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 14
Failure to Capture 37
Impedance Out of Range 2
Insulation (not further defined) 1
Lead Dislodgement 22
Other 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Conductor Fracture 2
Extra Cardiac Stimulation 93
Failure to Capture 60
Failure to Sense 1
Impedance Out of Range 10
Insulation Breach 1
Lead Dislodgement 209
Oversensing 1
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants68663
Estimated Active USA Implants47317
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution195284
Information

USA Returned Product Analysis

Conductor Fracture 23
Insulation Breach 2
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 35
Insulation Breach 3
Crimp/Weld/Bond 0
Other 12
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 Bipolar
More
Serial Number Prefix PVI
Lead Body Diameter 4.0 FR
Insulation Polyurethane (outer); SI-polyimide (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of April 11, 2019

www.medtronic.com/productperformance 651050