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            
% Survival 98.0 97.3 97.0 96.5            
#   1549 1147 608 135            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2015
Cumulative Months of Follow-Up 53327
Number of Leads Active in Study 1000
Information 51

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 12
Failure to Capture 17
Impedance Out of Range 1
Lead Dislodgement 19
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Extra Cardiac Stimulation 73
Failure to Capture 44
Failure to Sense 1
Impedance Out of Range 7
Insulation Breach 1
Lead Dislodgement 159
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants59563
Estimated Active USA Implants48922
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution121608
Information

USA Returned Product Analysis

Conductor Fracture 12
Insulation Breach 0
Crimp/Weld/Bond 0
Other 10
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 1
Crimp/Weld/Bond 0
Other 11
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 August 3, 2014

www.medtronic.com/productperformance 326050