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 at 66.0 mo        
% Survival 98.0 97.2 96.8 96.2 96.0 96.0        
#   1745 1299 947 624 236 98        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2153
Cumulative Months of Follow-Up 71283
Number of Leads Active in Study 818
Information 62

Qualifying Complications

Conductor Fracture 2
Extra Cardiac Stimulation 13
Failure to Capture 19
Impedance Out of Range 1
Insulation (not further defined) 1
Lead Dislodgement 21
Other 5
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 84
Failure to Capture 52
Failure to Sense 1
Impedance Out of Range 8
Insulation Breach 2
Lead Dislodgement 186
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants64767
Estimated Active USA Implants46740
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution167833
Information

USA Returned Product Analysis

Conductor Fracture 19
Insulation Breach 0
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 29
Insulation Breach 1
Crimp/Weld/Bond 0
Other 16
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 14, 2016

www.medtronic.com/productperformance 426050