5072 SureFix
Pacing
5072 SureFix
ALL
Information

Device Survival Probability

5072_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 99.7 99.7 99.2 99.2 99.2 99.2 98.4 98.4 97.3 97.3 97.3 97.3 97.3                
#   265 236 218 193 158 137 109 92 81 72 63 53 51                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 518
Cumulative Months of Follow-Up 23230
Number of Leads Active in Study 13
Information 4

Qualifying Complications

Cardiac Perforation 1
Failure to Capture 2
Failure to Sense 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Failure to Capture 2
Lead Dislodgement 2
Information

Distribution Data

US Market Release1998-06-05
CE Approval Date1997-09-25
Registered USA Implants10055
Estimated Active USA Implants3088
US Market Release1998-06-05
CE Approval Date1997-09-25
Estimated WW Distribution17753
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 9
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 15
Crimp/Weld/Bond 0
Other 0
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Fixed Screw
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium or Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LEM
Lead Body Diameter 7.2 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of July 31, 2017

www.medtronic.com/productperformance 501050