IMPLANTABLE PACING LEAD
This device is manufactured by MEDTRONIC.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Positioning Problem | 1 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Impedance Problem | 2 | Device |
| 2024 | High impedance | 1 | Device |
| 2024 | High Capture Threshold | 2 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Unspecified Infection | 5 | Patient |
| 2023 | Sepsis | 2 | Patient |
| 2023 | Insufficient Information | 3 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Erosion | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 2 | Patient |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High Capture Threshold | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Atrial Fibrillation | 1 | Patient |
| 2022 | Unstable Capture Threshold | 1 | Device |
| 2022 | Signal Artifact/Noise | 2 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Over-Sensing | 1 | Device |
| 2022 | Output Problem | 2 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Insufficient Information | 6 | Patient |
| 2021 | Pacing Problem | 2 | Device |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Output Problem | 2 | Device |
| 2021 | No Pacing | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2020 | Shock from Patient Lead(s) | 1 | Patient |
| 2020 | Insufficient Information | 3 | Patient |
| 2020 | Discomfort | 1 | Patient |
| 2020 | Device Overstimulation of Tissue | 1 | Patient |
| 2020 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2020 | Off-Label Use | 1 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2020 | Impedance Problem | 2 | Device |
| 2020 | High impedance | 1 | Device |
| 2020 | High Sensing Threshold | 1 | Device |
| 2020 | Failure to Capture | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Unspecified Infection | 2 | Patient |
| 2019 | Pacing Problem | 1 | Device |
| 2019 | Material Integrity Problem | 1 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Intermittent Capture | 1 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Impedance Problem | 1 | Device |
| 2019 | High impedance | 2 | Device |
| 2019 | High Capture Threshold | 5 | Device |
| 2019 | Fracture | 1 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 6 | Device |
| 2019 | Capturing Problem | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2019 | Activation, Positioning or Separation Problem | 1 | Device |
| 2018 | Unspecified Infection | 2 | Patient |
| 2018 | Shock from Patient Lead(s) | 1 | Patient |
| 2018 | Pocket Erosion | 1 | Patient |
| 2018 | Insufficient Information | 8 | Patient |
| 2018 | Unstable Capture Threshold | 1 | Device |
| 2018 | Under-Sensing | 2 | Device |
| 2018 | Product Quality Problem | 1 | Device |
| 2018 | Pocket Stimulation | 1 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Over-Sensing | 3 | Device |
| 2018 | Material Integrity Problem | 3 | Device |
| 2018 | Intermittent Capture | 2 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2018 | Impedance Problem | 2 | Device |
| 2018 | High impedance | 7 | Device |
| 2018 | High Sensing Threshold | 1 | Device |
| 2018 | High Capture Threshold | 11 | Device |
| 2018 | Fracture | 4 | Device |
| 2018 | Failure to Capture | 9 | Device |
| 2018 | Expulsion | 1 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 7 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Capturing Problem | 4 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2017 | Unspecified Infection | 4 | Patient |
| 2017 | Sepsis | 1 | Patient |
| 2017 | Insufficient Information | 7 | Patient |
| 2017 | Fall | 1 | Patient |
| 2017 | Signal Artifact/Noise | 1 | Device |
| 2017 | Positioning Problem | 2 | Device |
| 2017 | Pacing Problem | 2 | Device |
| 2017 | Over-Sensing | 2 | Device |
| 2017 | Low impedance | 2 | Device |
| 2017 | Intermittent Capture | 1 | Device |
| 2017 | Insufficient Information | 4 | Device |
| 2017 | Impedance Problem | 3 | Device |
| 2017 | High impedance | 4 | Device |
| 2017 | High Capture Threshold | 9 | Device |
| 2017 | Fracture | 2 | Device |
| 2017 | Failure to Capture | 3 | Device |
| 2017 | Device Dislodged or Dislocated | 11 | Device |
| 2017 | Defective Device | 1 | Device |
| 2017 | Connection Problem | 1 | Device |
| 2017 | Capturing Problem | 2 | Device |
| 2017 | Break | 3 | Device |
| 2017 | Appropriate Term/Code Not Available | 6 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2017 | Activation, Positioning or Separation Problem | 2 | Device |
| 2016 | Insufficient Information | 2 | Patient |
| 2016 | Use of Device Problem | 1 | Device |
| 2016 | Positioning Problem | 2 | Device |
| 2016 | Over-Sensing | 1 | Device |
| 2016 | Intermittent Capture | 1 | Device |
| 2016 | Impedance Problem | 2 | Device |
| 2016 | High impedance | 3 | Device |
| 2016 | High Capture Threshold | 17 | Device |
| 2016 | Fracture | 4 | Device |
| 2016 | Failure to Capture | 7 | Device |
| 2016 | Difficult to Remove | 3 | Device |
| 2016 | Device Sensing Problem | 1 | Device |
| 2016 | Device Handling Problem | 1 | Device |
| 2016 | Device Dislodged or Dislocated | 13 | Device |
| 2016 | Device Damaged by Another Device | 1 | Device |
| 2016 | Defective Device | 1 | Device |
| 2016 | Capturing Problem | 3 | Device |
| 2016 | Break | 4 | Device |
| 2016 | Appropriate Term/Code Not Available | 8 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Activation, Positioning or Separation Problem | 2 | Device |
| 2015 | Unspecified Infection | 1 | Patient |
| 2015 | Bacterial Infection | 1 | Patient |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Failure to Capture | 1 | Device |
| 2015 | Device Dislodged or Dislocated | 1 | Device |
| 2015 | Capturing Problem | 2 | Device |
| 2015 | Appropriate Term/Code Not Available | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2014 | Unspecified Infection | 3 | Patient |
| 2014 | Shock from Patient Lead(s) | 1 | Patient |
| 2014 | Insufficient Information | 9 | Patient |
| 2014 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2014 | Positioning Problem | 12 | Device |
| 2014 | Positioning Failure | 1 | Device |
| 2014 | Patient-Device Incompatibility | 3 | Device |
| 2014 | Pacing Problem | 2 | Device |
| 2014 | No Pacing | 1 | Device |
| 2014 | Material Separation | 1 | Device |
| 2014 | Intermittent Capture | 2 | Device |
| 2014 | Insufficient Information | 3 | Device |
| 2014 | High impedance | 2 | Device |
| 2014 | High Capture Threshold | 16 | Device |
| 2014 | Fracture | 1 | Device |
| 2014 | Failure to Convert Rhythm | 1 | Device |
| 2014 | Failure to Capture | 7 | Device |
| 2014 | Device Dislodged or Dislocated | 28 | Device |
| 2014 | Device Disinfection Or Sterilization Issue | 1 | Device |
| 2014 | Device Contamination with Body Fluid | 1 | Device |
| 2014 | Capturing Problem | 4 | Device |
| 2014 | Break | 2 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2014 | Activation, Positioning or Separation Problem | 2 | Device |
| 2013 | Unspecified Infection | 4 | Patient |
| 2013 | Undesired Nerve Stimulation | 3 | Patient |
| 2013 | Tachycardia | 1 | Patient |
| 2013 | Insufficient Information | 21 | Patient |
| 2013 | Failure of Implant | 1 | Patient |
| 2013 | Device Overstimulation of Tissue | 3 | Patient |
| 2013 | Appropriate Term / Code Not Available | 1 | Patient |
| 2013 | Use of Device Problem | 1 | Device |
| 2013 | Unstable Capture Threshold | 1 | Device |
| 2013 | Therapeutic or Diagnostic Output Failure | 3 | Device |
| 2013 | Signal Artifact/Noise | 1 | Device |
| 2013 | Positioning Problem | 3 | Device |
| 2013 | Patient-Device Incompatibility | 1 | Device |
| 2013 | Pacing Problem | 1 | Device |
| 2013 | Over-Sensing | 2 | Device |
| 2013 | Migration | 1 | Device |
| 2013 | Low impedance | 1 | Device |
| 2013 | Insufficient Information | 4 | Device |
| 2013 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2013 | Impedance Problem | 1 | Device |
| 2013 | High impedance | 1 | Device |
| 2013 | High Sensing Threshold | 1 | Device |
| 2013 | High Capture Threshold | 5 | Device |
| 2013 | Failure to Capture | 2 | Device |
| 2013 | Difficult or Delayed Positioning | 1 | Device |
| 2013 | Device Sensing Problem | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 15 | Device |
| 2013 | Defibrillation/Stimulation Problem | 1 | Device |
| 2013 | Collapse | 1 | Device |
| 2013 | Capturing Problem | 1 | Device |
| 2013 | Appropriate Term/Code Not Available | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2012 | Unspecified Infection | 4 | Patient |
| 2012 | Undesired Nerve Stimulation | 1 | Patient |
| 2012 | Syncope/Fainting | 1 | Patient |
| 2012 | Insufficient Information | 20 | Patient |
| 2012 | Decreased Respiratory Rate | 1 | Patient |
| 2012 | Appropriate Term / Code Not Available | 1 | Patient |
| 2012 | Therapeutic or Diagnostic Output Failure | 6 | Device |
| 2012 | Positioning Problem | 2 | Device |
| 2012 | Over-Sensing | 2 | Device |
| 2012 | Intermittent Capture | 1 | Device |
| 2012 | Insufficient Information | 2 | Device |
| 2012 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2012 | Impedance Problem | 1 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | High Capture Threshold | 2 | Device |
| 2012 | Display or Visual Feedback Problem | 1 | Device |
| 2012 | Device Dislodged or Dislocated | 7 | Device |
| 2012 | Battery Problem: High Impedance | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2011 | Undesired Nerve Stimulation | 1 | Patient |
| 2011 | Syncope/Fainting | 1 | Patient |
| 2011 | Insufficient Information | 29 | Patient |
| 2011 | Hypernatremia | 1 | Patient |
| 2011 | Discomfort | 1 | Patient |
| 2011 | Device Overstimulation of Tissue | 5 | Patient |
| 2011 | Unstable | 1 | Device |
| 2011 | Unintended Movement | 1 | Device |
| 2011 | Unexpected Therapeutic Results | 1 | Device |
| 2011 | Therapeutic or Diagnostic Output Failure | 6 | Device |
| 2011 | Product Quality Problem | 1 | Device |
| 2011 | Patient-Device Incompatibility | 1 | Device |
| 2011 | Misconnection | 1 | Device |
| 2011 | Misassembled | 1 | Device |
| 2011 | Malposition of Device | 2 | Device |
| 2011 | Insufficient Information | 5 | Device |
| 2011 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2011 | High Capture Threshold | 2 | Device |
| 2011 | Failure to Capture | 4 | Device |
| 2011 | Failure to Advance | 3 | Device |
| 2011 | Difficult or Delayed Positioning | 6 | Device |
| 2011 | Device Sensing Problem | 1 | Device |
| 2011 | Device Dislodged or Dislocated | 2 | Device |
| 2011 | Appropriate Term/Code Not Available | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2010 | Device Overstimulation of Tissue | 1 | Patient |
| 2010 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2010 | Device Dislodged or Dislocated | 1 | Device |