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
2188 Attain CS
3830 SelectSecure
4023 CapSure SP
4024 CapSure SP
4033 CapSure Z
4067 CapSureFix
4068 CapSureFix
4073 CapSure Sense
4074 CapSure Sense
4076 CapSureFix Novus
4080 PASS FIX MRI
4084MRI CapSure Sense MRI
4092 CapSure SP Novus
4193 Attain OTW
4194 Attain OTW
4195 Attain StarFix
4196 Attain Ability
4296 Attain Ability Plus
4396 Attain Ability Straight
4523 CapSure SP
4524 CapSure SP
4533 CapSure Z
4558M Screw-In
4568 CapSureFix
4574 CapSure Sense
4580 PASS FIX MRI
4584MRI CapSure Sense MRI
4592 CapSure SP Novus
4951 Spectraflex
4951M Spectraflex
4965 CapSure Epi
4968 CapSure Epi
5023 CapSure SP
5023M CapSure SP
5024 CapSure SP
5024M CapSure SP
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
5524 CapSure SP
5524M CapSure SP
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
6936 Transvene
6940 CapSureFix
6942 Sprint
6943 Sprint
6944 Sprint Quattro
6945 Sprint
6947 Sprint Quattro Secure
6947M Sprint Quattro Secure
6948 Sprint Fidelis
6948M
6949 Sprint Fidelis
6949M
6966 Transvene
ICF09B Crystalline
ICL08 Crystalline
ICL08B Crystalline
ICL08JB Crystalline
ICM09 Crystalline
ICM09B Crystalline
ICM09JB Crystalline
ICQ09B Crystalline
IHP09B Impulse II
IHP09JB Impulse II
IMD19 Excellence+
IMD19B Excellence+
IMD19JB Excellence+
IMD49 Excellence+
IMD49B Excellence+
IMD49JB Excellence+
IME49 Excellence S+
IME49B Excellence S+
IME49JB Excellence S+
IMG49 Impulse
IMG49B Impulse
IMG49JB Impulse
IMK49B Excellence PS+
IMK49JB Excellence PS+
IML49B Excellence SS+
IML49JB Excellence SS+
IMP15Q Brilliant+
IMP16Q Brilliant+
IMP17Q Brilliant+
IMP18Q Brilliant+
IMR15Q Brilliant+
IMR16Q Brilliant+
IMR17Q Brilliant+
IMR18Q Brilliant+
IMS19B Pirouet
IMS49 Pirouet
IMS49B Pirouet
IMS49J Pirouet
IMS49JB Pirouet
IMT49 Silhouet
IMU49 Pirouet
IMU49B Pirouet
IMU49JB Pirouet
IMV49B Silhouet
IMV49J Silhouet
IMW14Q Brilliant S+ VDD
IMW15Q Brilliant S+ VDD
IMW16Q Brilliant S+ VDD
IMW17Q Brilliant S+ VDD
IMW18Q Brilliant S+ VDD
IMX49 Pirouet S+
IMX49B Pirouet S+
IMX49JB Pirouet S+
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