Performance Notes
Tests and Observations for Clinical Assessment of Chronic Pacing Leads

Tests and Observations for Clinical Assessment of Chronic Pacing Leads

View specific models that this applies to

 

Test/Observation Possible Insulation Failure Possible Conductor Failure Possible Other System Failure Effect on Test/ Observation
Sudden and Significant
Decrease
Sudden and Significant Increase
Dislodgement Decrease
Perforation Increase or Decrease
Electrolyte Imbalance Increase or Decrease
Improper IPG/Lead Connection Increase or Decrease
Sudden and Significant Increase, Especially in Bipolar System Sudden and Significant Increase
Dislodgement Increase
Exit Block Increase
Infarct at Electrode Site Increase
Perforation Increase
Improper IPG/Lead Connection Increase
Sudden and Significant Decrease in Amplitudes and/or Slew Rates for P and/or R Waves Sudden and Significant Decrease or Disappearance of Amplitudes and/or Slew Rates for P and/or R Waves
Dislodgement Decrease
Perforation Decrease
Infarct at Electrode Site Decrease
Electrolyte Imbalance Decrease
Improper IPG/Lead Connection Decrease
Sudden Increase in Ratios of Leading-Edge Voltages to Trailing-Edge Voltages (i.e., over 25% increase) Intermittent or No Pacer Artifacts (Even in Asynchronous Mode) Improper IPG/Lead Connection Intermittent or No Pacer Artifacts
(Even in Asynchronous Mode)
Not Discernible Visual Observation of Conductor/Connector/ Electrode Fracture (Sometimes Discernible)

Dislodgement or Perforation.
Improper IPG/Lead Connection.

Sometimes Discernible

Insulation Breach and/or Degradation, or Ligature Cut-Through Not Easily Discernible Connector Defect or Connector Pulled Apart. Improper IPG/Lead Connection. Sometimes Discernible
Sudden Onset, Especially in Bipolar System   Connector Defect in Bipolar or Unipolar. Hypersensitivity to Unipolar Pulse Generator Can. Anti-Stim Coating or Protection Deficient.  
Sudden Onset in Bipolar or Unipolar Systems   Perforation or Displacement of Atrial Lead (Phrenic Nerve)  
Sudden Onset and Significant Change, Especially in Bipolar System (Increase in Size) Sudden Changes, Usually a Decrease in Size Perforation or Dislodgement. Connector Defect. Improper
IPG/Lead Connection.
Sometimes Discernible
Sudden Onset, Especially in Bipolar Systems   Physical Contact between the Electrode(s) on the Lead and that of Another Lead. Inappropriate IPG Parameter Setting. Improper IPG/Lead Connection. Sometimes Discernible
Sudden Onset in Either Unipolar or Bipolar Systems Sudden Onset in Either Unipolar or Bipolar Systems Dislodgement or Perforation. Infarct at Electrode Site. Electrolyte Imbalance. Inappropriate IPG Parameter Setting. Improper IPG/Lead Connection. Sometimes Discernible
See “Pacing Thresholds" Above See “Pacing Thresholds” Above See “Pacing Thresholds” Above  

Specific Models This Applies To

2187 Attain LV
3830 SelectSecure
4024 CapSure SP
4068 CapSureFix
4074 CapSure Sense
4076 CapSureFix Novus
4092 CapSure SP Novus
4193 Attain OTW
4194 Attain OTW
4195 Attain StarFix
4196 Attain Ability
4296 Attain Ability Plus
4396 Attain Ability Straight
4524 CapSure SP
4558M Screw-In
4568 CapSureFix
4574 CapSure Sense
4592 CapSure SP Novus
4965 CapSure Epi
4968 CapSure Epi
5032 CapSure VDD
5033 CapSure Z
5034 CapSure Z
5038 CapSure VDD-2
5054 CapSure Z Novus
5068 CapSureFix
5071 Screw-in
5072 SureFix
5076 CapSureFix Novus
5086MRI CapsureFix Novus MRI
5092 CapSure SP Novus
5534 CapSure Z
5554 CapSure Z Novus
5568 CapSureFix
5592 CapSure SP Novus
5594 CapSure SP Novus
6930 Sprint Fidelis
6931 Sprint Fidelis
6932 Sprint
6935 Sprint Quattro Secure
6940 CapSureFix
6942 Sprint
6943 Sprint
6944 Sprint Quattro
6945 Sprint
6947 Sprint Quattro Secure
6947M Sprint Quattro Secure
6948 Sprint Fidelis
6949 Sprint Fidelis
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