Customer Communications
Performance Note: Tests and Observations for Clinical Assessment of Chronic Pacing Leads

Performance Note: Tests and Observations for Clinical Assessment of Chronic Pacing Leads

Chronic Pacing Leads
Original Date of Communication: January 1992

View specific models that this applies to

Test/Observation

Possible Insulation Failure

Possible Conductor Failure

Possible Other System Failure

Effect on Test/ Observation

Pacing Impedance
(Telemetered or Measured Invasively)

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

AnchorPacing Thresholds
(Telemetered/ Programmed or Measured Invasively)

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

Electrograms
(Telemetered or Measured Invasively)

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

Waveform Analysis
(Oscillographs of Pacer Artifact from ECG Electrodes)

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)

Radiographs
(Post-Implant, Recent, Current)

Not Discernible

Visual Observation of Conductor/Connector/ Electrode Fracture (Sometimes Discernible)

Dislodgement or Perforation.
Improper IPG/Lead Connection.

Sometimes Discernible

Visual Inspection
(Invasive)

Insulation Breach and/or Degradation, or Ligature Cut-Through

Not Easily Discernible

Connector Defect or Connector Pulled Apart. Improper IPG/Lead Connection.

Sometimes Discernible

Pectoral Muscle Stimulation

Sudden Onset, Especially in Bipolar System

 

Connector Defect in Bipolar or Unipolar. Hypersensitivity to Unipolar Pulse Generator Can. Anti-Stim Coating or Protection Deficient.

 

Phrenic Nerve/
Diaphragmatic Stimulation

Sudden Onset in Bipolar or Unipolar Systems

 

Perforation or Displacement of Atrial Lead (Phrenic Nerve)

 

Pacemaker ECG Stimulus
Artifact Size and Morphology Change (May Not Be Possible with Digital ECG)

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

Oversensing
(Intermittent or Continuous)

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

Undersensing
(Intermittent or Continuous)

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

Loss of Capture

See “Pacing Thresholds" Above

See “Pacing Thresholds” Above

See “Pacing Thresholds” Above

 

Specific Models This Applies To

2187 Attain LV
3830 SelectSecure
4073 CapSure Sense
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
4298 Attain Performa
4396 Attain Ability Straight
4398 Attain Performa Straight
4574 CapSure Sense
4592 CapSure SP Novus
4598 Attain Performa S
4965 CapSure Epi
4968 CapSure Epi
5038 CapSure VDD-2
5054 CapSure Z Novus
5071 Screw-in
5076 CapSureFix Novus
5086MRI CapsureFix Novus MRI
5092 CapSure SP Novus
5554 CapSure Z Novus
5592 CapSure SP Novus
5594 CapSure SP Novus
6930 Sprint Fidelis
6931 Sprint Fidelis
6935 Sprint Quattro Secure S
6935M Sprint Quattro Secure S
6944 Sprint Quattro
6946M Sprint Quattro
6947 Sprint Quattro Secure
6947M Sprint Quattro Secure
6948 Sprint Fidelis
6949 Sprint Fidelis
www.medtronic.com/productperformance 726050