IMPLANTABLE PACING LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC IRELAND.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Presyncope | 1 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Bacteremia | 1 | Patient |
| 2024 | Asystole | 2 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Unstable Capture Threshold | 3 | Device |
| 2024 | Under-Sensing | 3 | Device |
| 2024 | Signal Artifact/Noise | 1 | Device |
| 2024 | Pocket Stimulation | 1 | Device |
| 2024 | Pacing Problem | 2 | Device |
| 2024 | Low impedance | 2 | Device |
| 2024 | High impedance | 3 | Device |
| 2024 | High Capture Threshold | 3 | Device |
| 2024 | Fracture | 2 | Device |
| 2024 | Failure to Capture | 4 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Decreased Sensitivity | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2023 | Obstruction/Occlusion | 1 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Fatigue | 2 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Dizziness | 4 | Patient |
| 2023 | Bradycardia | 4 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Unstable Capture Threshold | 3 | Device |
| 2023 | Under-Sensing | 3 | Device |
| 2023 | Signal Artifact/Noise | 1 | Device |
| 2023 | Pacing Problem | 2 | Device |
| 2023 | Over-Sensing | 4 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Intermittent Capture | 2 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High impedance | 4 | Device |
| 2023 | High Capture Threshold | 9 | Device |
| 2023 | Failure to Capture | 4 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Decreased Sensitivity | 2 | Device |
| 2023 | Capturing Problem | 1 | Device |
| 2023 | Ambient Noise Problem | 1 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Tachycardia | 2 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Erosion | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Atrial Fibrillation | 1 | Patient |
| 2022 | Arrhythmia | 1 | Patient |
| 2022 | Under-Sensing | 3 | Device |
| 2022 | Signal Artifact/Noise | 3 | Device |
| 2022 | Protective Measures Problem | 1 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 5 | Device |
| 2022 | Low impedance | 3 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Impedance Problem | 5 | Device |
| 2022 | High impedance | 7 | Device |
| 2022 | High Capture Threshold | 7 | Device |
| 2022 | Fracture | 2 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Electrical /Electronic Property Problem | 2 | Device |
| 2022 | Compatibility Problem | 1 | Device |
| 2022 | Capturing Problem | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2021 | Insufficient Information | 3 | Patient |
| 2021 | Unstable Capture Threshold | 1 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2021 | Material Integrity Problem | 1 | Device |
| 2021 | Low impedance | 2 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Impedance Problem | 2 | Device |
| 2021 | High impedance | 2 | Device |
| 2021 | High Capture Threshold | 1 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Break | 1 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Impedance Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Unspecified Infection | 3 | Patient |
| 2019 | Insufficient Information | 2 | Patient |
| 2019 | Foreign Body In Patient | 1 | Patient |
| 2019 | Unstable Capture Threshold | 5 | Device |
| 2019 | Under-Sensing | 3 | Device |
| 2019 | Signal Artifact/Noise | 8 | Device |
| 2019 | Pocket Stimulation | 1 | Device |
| 2019 | Pacing Problem | 7 | Device |
| 2019 | Over-Sensing | 10 | Device |
| 2019 | Material Erosion | 1 | Device |
| 2019 | Low impedance | 9 | Device |
| 2019 | Insufficient Information | 5 | Device |
| 2019 | Impedance Problem | 9 | Device |
| 2019 | High impedance | 10 | Device |
| 2019 | High Capture Threshold | 22 | Device |
| 2019 | Fracture | 11 | Device |
| 2019 | Failure to Capture | 7 | Device |
| 2019 | Electrical /Electronic Property Problem | 5 | Device |
| 2019 | Device Sensing Problem | 2 | Device |
| 2019 | Capturing Problem | 7 | Device |
| 2019 | Break | 7 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2018 | Insufficient Information | 7 | Patient |
| 2018 | Foreign Body In Patient | 2 | Patient |
| 2018 | Unstable Capture Threshold | 10 | Device |
| 2018 | Under-Sensing | 2 | Device |
| 2018 | Signal Artifact/Noise | 12 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Pacing Problem | 8 | Device |
| 2018 | Over-Sensing | 22 | Device |
| 2018 | No Pacing | 2 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Low impedance | 9 | Device |
| 2018 | Intermittent Capture | 6 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Impedance Problem | 16 | Device |
| 2018 | High impedance | 25 | Device |
| 2018 | High Sensing Threshold | 2 | Device |
| 2018 | High Capture Threshold | 37 | Device |
| 2018 | Fracture | 6 | Device |
| 2018 | Failure to Sense | 2 | Device |
| 2018 | Failure to Capture | 18 | Device |
| 2018 | Electrical /Electronic Property Problem | 6 | Device |
| 2018 | Device Sensing Problem | 2 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 3 | Device |
| 2018 | Degraded | 1 | Device |
| 2018 | Decreased Sensitivity | 1 | Device |
| 2018 | Connection Problem | 2 | Device |
| 2018 | Collapse | 1 | Device |
| 2018 | Capturing Problem | 16 | Device |
| 2018 | Break | 5 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2017 | Unspecified Infection | 4 | Patient |
| 2017 | Insufficient Information | 11 | Patient |
| 2017 | Unstable Capture Threshold | 8 | Device |
| 2017 | Under-Sensing | 6 | Device |
| 2017 | Signal Artifact/Noise | 13 | Device |
| 2017 | Product Quality Problem | 1 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Pacing Problem | 5 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 2 | Device |
| 2017 | Over-Sensing | 13 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Low impedance | 3 | Device |
| 2017 | Intermittent Capture | 3 | Device |
| 2017 | Insufficient Information | 5 | Device |
| 2017 | Incorrect Interpretation of Signal | 1 | Device |
| 2017 | Impedance Problem | 12 | Device |
| 2017 | High impedance | 15 | Device |
| 2017 | High Capture Threshold | 30 | Device |
| 2017 | Fracture | 10 | Device |
| 2017 | Failure to Sense | 2 | Device |
| 2017 | Failure to Capture | 15 | Device |
| 2017 | Electronic Property Issue | 5 | Device |
| 2017 | Device Sensing Problem | 3 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Collapse | 1 | Device |
| 2017 | Capturing Problem | 7 | Device |
| 2017 | Break | 2 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2016 | Insufficient Information | 5 | Patient |
| 2016 | Use of Device Problem | 1 | Device |
| 2016 | Unstable Capture Threshold | 11 | Device |
| 2016 | Under-Sensing | 1 | Device |
| 2016 | Signal Artifact/Noise | 7 | Device |
| 2016 | Positioning Problem | 2 | Device |
| 2016 | Patient Device Interaction Problem | 1 | Device |
| 2016 | Pacing Problem | 8 | Device |
| 2016 | Over-Sensing | 17 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Low impedance | 8 | Device |
| 2016 | Intermittent Capture | 5 | Device |
| 2016 | Impedance Problem | 11 | Device |
| 2016 | High impedance | 16 | Device |
| 2016 | High Capture Threshold | 28 | Device |
| 2016 | Fracture | 11 | Device |
| 2016 | Failure to Sense | 2 | Device |
| 2016 | Failure to Capture | 13 | Device |
| 2016 | Electronic Property Issue | 4 | Device |
| 2016 | Electrical /Electronic Property Problem | 1 | Device |
| 2016 | Device-Device Incompatibility | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 1 | Device |
| 2016 | Device Dislodged or Dislocated | 5 | Device |
| 2016 | Decreased Sensitivity | 1 | Device |
| 2016 | Connection Problem | 2 | Device |
| 2016 | Component Missing | 1 | Device |
| 2016 | Capturing Problem | 4 | Device |
| 2016 | Break | 5 | Device |
| 2016 | Appropriate Term/Code Not Available | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2015 | Insufficient Information | 1 | Patient |
| 2015 | Signal Artifact/Noise | 1 | Device |
| 2015 | Over-Sensing | 1 | Device |
| 2015 | Low impedance | 2 | Device |
| 2015 | Impedance Problem | 1 | Device |
| 2015 | High Capture Threshold | 3 | Device |
| 2015 | Failure to Capture | 2 | Device |
| 2015 | Electronic Property Issue | 1 | Device |
| 2015 | Degraded | 1 | Device |
| 2015 | Capturing Problem | 1 | Device |
| 2015 | Break | 1 | Device |
| 2014 | Insufficient Information | 2 | Patient |
| 2014 | Unstable Capture Threshold | 6 | Device |
| 2014 | Under-Sensing | 2 | Device |
| 2014 | Signal Artifact/Noise | 4 | Device |
| 2014 | Pacing Problem | 4 | Device |
| 2014 | Over-Sensing | 7 | Device |
| 2014 | Material Integrity Problem | 1 | Device |
| 2014 | Low impedance | 7 | Device |
| 2014 | Intermittent Capture | 7 | Device |
| 2014 | Impedance Problem | 6 | Device |
| 2014 | High impedance | 10 | Device |
| 2014 | High Capture Threshold | 18 | Device |
| 2014 | Fracture | 7 | Device |
| 2014 | Failure to Sense | 2 | Device |
| 2014 | Failure to Capture | 7 | Device |
| 2014 | Failure to Advance | 1 | Device |
| 2014 | Electronic Property Issue | 1 | Device |
| 2014 | Difficult to Remove | 1 | Device |
| 2014 | Device Sensing Problem | 1 | Device |
| 2014 | Device Dislodged or Dislocated | 4 | Device |
| 2014 | Defective Device | 1 | Device |
| 2014 | Collapse | 1 | Device |
| 2014 | Capturing Problem | 10 | Device |
| 2014 | Break | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Unspecified Infection | 1 | Patient |
| 2013 | Insufficient Information | 8 | Patient |
| 2013 | Foreign Body In Patient | 2 | Patient |
| 2013 | Unstable Capture Threshold | 3 | Device |
| 2013 | Under-Sensing | 1 | Device |
| 2013 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2013 | Signal Artifact/Noise | 3 | Device |
| 2013 | Positioning Problem | 1 | Device |
| 2013 | Over-Sensing | 2 | Device |
| 2013 | Operating System Version or Upgrade Problem | 1 | Device |
| 2013 | Material Deformation | 1 | Device |
| 2013 | Low impedance | 1 | Device |
| 2013 | Intermittent Capture | 4 | Device |
| 2013 | Insufficient Information | 3 | Device |
| 2013 | Impedance Problem | 3 | Device |
| 2013 | High impedance | 7 | Device |
| 2013 | High Capture Threshold | 3 | Device |
| 2013 | Fracture | 4 | Device |
| 2013 | Failure to Capture | 2 | Device |
| 2013 | Device Dislodged or Dislocated | 1 | Device |
| 2013 | Degraded | 1 | Device |
| 2013 | Capturing Problem | 2 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2013 | Activation, Positioning or Separation Problem | 1 | Device |
| 2012 | Syncope/Fainting | 1 | Patient |
| 2012 | Insufficient Information | 6 | Patient |
| 2012 | No Pacing | 1 | Device |
| 2012 | Material Perforation | 1 | Device |
| 2012 | Intermittent Capture | 1 | Device |
| 2012 | Insufficient Information | 1 | Device |
| 2012 | Impedance Problem | 2 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | Crack | 1 | Device |
| 2011 | Unspecified Infection | 1 | Patient |
| 2011 | Pain | 2 | Patient |
| 2011 | Insufficient Information | 9 | Patient |
| 2011 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2011 | Signal Artifact/Noise | 2 | Device |
| 2011 | Positioning Problem | 1 | Device |
| 2011 | Over-Sensing | 1 | Device |
| 2011 | Misconnection | 1 | Device |
| 2011 | Insufficient Information | 3 | Device |
| 2011 | Impedance Problem | 1 | Device |
| 2011 | High Capture Threshold | 1 | Device |
| 2011 | Failure to Capture | 1 | Device |
| 2011 | Connection Problem | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2010 | Insufficient Information | 2 | Patient |
| 2010 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2009 | Device Dislodged or Dislocated | 1 | Device |
| 2009 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2008 | Pacing Problem | 1 | Device |
| 2008 | Kinked | 1 | Device |
| 2008 | Impedance Problem | 1 | Device |
| 2008 | Device Sensing Problem | 1 | Device |
| 2008 | Appropriate Term/Code Not Available | 1 | Device |
| 2008 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2006 | Appropriate Term/Code Not Available | 1 | Device |
| 2004 | Impedance Problem | 1 | Device |
| 2004 | High impedance | 1 | Device |
| 2004 | High Capture Threshold | 1 | Device |
| 2003 | Impedance Problem | 1 | Device |
| 2003 | High impedance | 1 | Device |
| 2003 | High Capture Threshold | 1 | Device |
| 2002 | Device Dislodged or Dislocated | 1 | Device |
| 2000 | Over-Sensing | 1 | Device |