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 at 78.0 mo      
% Survival 98.0 97.2 96.7 96.1 96.0 95.2 94.5      
#   1801 1386 1038 750 574 194 82      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2207
Cumulative Months of Follow-Up 81618
Number of Leads Active in Study 696
Information 69

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 13
Failure to Capture 28
Impedance Out of Range 1
Insulation (not further defined) 1
Lead Dislodgement 21
Other 2
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 85
Failure to Capture 56
Failure to Sense 1
Impedance Out of Range 8
Insulation Breach 1
Lead Dislodgement 198
Oversensing 1
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants66561
Estimated Active USA Implants47256
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution176944
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 February 3, 2017

www.medtronic.com/productperformance 476050