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 9 yr 10 yr 11 yr 12 yr at 150.0 mo                
% Survival 98.0 97.3 96.6 95.9 95.7 95.2 94.8 94.2 93.9 93.6 93.6 93.1 93.1                
#   1884 1494 1189 960 788 632 491 407 328 248 187 109 62                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2319
Cumulative Months of Follow-Up 117864
Number of Leads Active in Study 233
Information 87

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 17
Failure to Capture 37
Impedance Out of Range 2
Insulation (not further defined) 1
Lead Dislodgement 23
Other 4
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Conductor Fracture 2
Extra Cardiac Stimulation 98
Failure to Capture 66
Failure to Sense 1
Impedance Out of Range 12
Insulation Breach 1
Lead Dislodgement 228
Oversensing 1
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2009-05-15
CE Approval Date2007-07-24
Registered USA Implants68859
Estimated Active USA Implants27862
US Market Release2009-05-15
CE Approval Date2007-07-24
Estimated WW Distribution220961
Information

USA Returned Product Analysis

Conductor Fracture 26
Insulation Breach 2
Crimp/Weld/Bond 0
Other 9
Information

WW Returned Product Analysis

Conductor Fracture 38
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 December 1, 2023

www.medtronic.com/productperformance 951051