4598 Attain Performa S
Left-Heart Pacing
4598 Attain Performa S
ALL
Information

Device Survival Probability

4598_SURV
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    1 yr 2 yr at 30.0 mo              
% Survival 99.1 99.1 99.1              
#   467 218 118              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 915
Cumulative Months of Follow-Up 13062
Number of Leads Active in Study 746
Information 6

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 5
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 6
Conductor Fracture 1
Extra Cardiac Stimulation 53
Failure to Capture 27
Impedance Out of Range 5
Lead Dislodgement 29
Oversensing 1
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants30608
Estimated Active USA Implants29305
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution64253
Information

USA Returned Product Analysis

Conductor Fracture 3
Insulation Breach 1
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 1
Crimp/Weld/Bond 0
Other 6
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Canted
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Quad Pole
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Serial Number Prefix QUC
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) SI-polyimide (SI-PI)(inner)
Pace/Sense Connector Style IS4-LLLL
High Voltage Connector n/a
Steroid Yes
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Data as of October 12, 2018

www.medtronic.com/productperformance 626050