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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Sudden and Significant Decrease |
Sudden and Significant Increase |
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| Sudden and Significant Increase, Especially in Bipolar System | Sudden and Significant Increase |
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| 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 |
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| 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) |
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| Not Discernible | Visual Observation of Conductor/Connector/ Electrode Fracture (Sometimes Discernible) |
Dislodgement or Perforation. |
Sometimes Discernible |
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| 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
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