4398 Attain Performa Straight
Left-Heart Pacing
4398 Attain Performa Straight
ALL
Information

Device Survival Probability

4398_SURV
Loading...











    1 yr 2 yr 3 yr              
% Survival 99.8 99.8 99.0              
#   364 172 65              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 886
Cumulative Months of Follow-Up 11376
Number of Leads Active in Study 730
Information 3

Qualifying Complications

Failure to Capture 2
Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Extra Cardiac Stimulation 53
Failure to Capture 30
Impedance Out of Range 4
Lead Dislodgement 15
Information

Distribution Data

US Market Release2014-12-10
CE Approval Date2013-01-01
Registered USA Implants19211
Estimated Active USA Implants18313
US Market Release2014-12-10
CE Approval Date2013-01-01
Estimated WW Distribution39215
Information

USA Returned Product Analysis

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

WW Returned Product Analysis

Conductor Fracture 2
Insulation Breach 0
Crimp/Weld/Bond 0
Other 3
Information

Product Characteristics

Lead Type Left-Heart
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Left Ventricular Cardiac Vein
Pace/Sense Polarity Bipolar
More
Serial Number Prefix QUB
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-4
High Voltage Connector n/a
Steroid Yes
Hide this content

Data as of April 11, 2019

www.medtronic.com/productperformance 651050