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

Tests and Observations for Clinical Assessment of Chronic Pacing Leads

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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

www.medtronic.com/productperformance 451050