DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
This device is manufactured by MEDTRONIC, RICE CREEK MFG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Over-Sensing | 2 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Intermittent Capture | 2 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 1 | Device |
| 2024 | Fracture | 4 | Device |
| 2024 | Failure to Capture | 3 | Device |
| 2024 | Electrical /Electronic Property Problem | 2 | Device |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Unstable Capture Threshold | 1 | Device |
| 2023 | Under-Sensing | 1 | Device |
| 2023 | Pacing Problem | 3 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 3 | Device |
| 2023 | High Capture Threshold | 1 | Device |
| 2023 | Fracture | 3 | Device |
| 2023 | Failure to Capture | 4 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Decreased Sensitivity | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Over-Sensing | 1 | Device |
| 2022 | Material Separation | 2 | Device |
| 2022 | Low impedance | 4 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 3 | Device |
| 2022 | High Capture Threshold | 2 | Device |
| 2022 | Fracture | 7 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2020 | Low impedance | 1 | Device |
| 2019 | Unstable Capture Threshold | 1 | Device |
| 2019 | Under-Sensing | 7 | Device |
| 2019 | Signal Artifact/Noise | 4 | Device |
| 2019 | Positioning Problem | 3 | Device |
| 2019 | Pacing Problem | 3 | Device |
| 2019 | Over-Sensing | 8 | Device |
| 2019 | Low impedance | 10 | Device |
| 2019 | Intermittent Capture | 2 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Impedance Problem | 2 | Device |
| 2019 | High impedance | 16 | Device |
| 2019 | High Capture Threshold | 8 | Device |
| 2019 | Fracture | 24 | Device |
| 2019 | Failure to Sense | 3 | Device |
| 2019 | Failure to Capture | 3 | Device |
| 2019 | Electrical /Electronic Property Problem | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Degraded | 1 | Device |
| 2019 | Capturing Problem | 1 | Device |
| 2019 | Break | 8 | Device |
| 2018 | Unstable Capture Threshold | 3 | Device |
| 2018 | Under-Sensing | 3 | Device |
| 2018 | Signal Artifact/Noise | 3 | Device |
| 2018 | Shelf Life Exceeded | 1 | Device |
| 2018 | Premature Discharge of Battery | 1 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Over-Sensing | 9 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Low impedance | 15 | Device |
| 2018 | Intermittent Capture | 1 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Impedance Problem | 9 | Device |
| 2018 | High impedance | 21 | Device |
| 2018 | High Sensing Threshold | 3 | Device |
| 2018 | High Capture Threshold | 20 | Device |
| 2018 | Fracture | 26 | Device |
| 2018 | Failure to Sense | 1 | Device |
| 2018 | Failure to Capture | 15 | Device |
| 2018 | Display or Visual Feedback Problem | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 1 | Device |
| 2018 | Degraded | 1 | Device |
| 2018 | Capturing Problem | 9 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2017 | Unstable Capture Threshold | 8 | Device |
| 2017 | Under-Sensing | 3 | Device |
| 2017 | Signal Artifact/Noise | 8 | Device |
| 2017 | Pacing Problem | 3 | Device |
| 2017 | Over-Sensing | 6 | Device |
| 2017 | Material Integrity Problem | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Low impedance | 10 | Device |
| 2017 | Intermittent Capture | 2 | Device |
| 2017 | Impedance Problem | 5 | Device |
| 2017 | High impedance | 36 | Device |
| 2017 | High Capture Threshold | 32 | Device |
| 2017 | Fracture | 45 | Device |
| 2017 | Failure to Sense | 1 | Device |
| 2017 | Failure to Capture | 13 | Device |
| 2017 | Device Sensing Problem | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Contamination with Body Fluid | 1 | Device |
| 2017 | Decreased Sensitivity | 1 | Device |
| 2017 | Capturing Problem | 5 | Device |
| 2017 | Break | 9 | Device |
| 2017 | Appropriate Term/Code Not Available | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Undesired Nerve Stimulation | 1 | Patient |
| 2016 | Dizziness | 1 | Patient |
| 2016 | Device Overstimulation of Tissue | 1 | Patient |
| 2016 | Unstable Capture Threshold | 4 | Device |
| 2016 | Signal Artifact/Noise | 1 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Over-Sensing | 2 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Low impedance | 5 | Device |
| 2016 | Loose or Intermittent Connection | 1 | Device |
| 2016 | Impedance Problem | 10 | Device |
| 2016 | High impedance | 22 | Device |
| 2016 | High Sensing Threshold | 1 | Device |
| 2016 | High Capture Threshold | 20 | Device |
| 2016 | Fracture | 20 | Device |
| 2016 | Failure to Capture | 18 | Device |
| 2016 | Device Sensing Problem | 3 | Device |
| 2016 | Device Dislodged or Dislocated | 1 | Device |
| 2016 | Cut In Material | 1 | Device |
| 2016 | Connection Problem | 1 | Device |
| 2016 | Capturing Problem | 9 | Device |
| 2016 | Appropriate Term/Code Not Available | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2015 | Signal Artifact/Noise | 1 | Device |
| 2015 | Low impedance | 1 | Device |
| 2015 | Intermittent Capture | 1 | Device |
| 2015 | Impedance Problem | 2 | Device |
| 2015 | High impedance | 5 | Device |
| 2015 | High Capture Threshold | 6 | Device |
| 2015 | Fracture | 8 | Device |
| 2015 | Failure to Capture | 4 | Device |
| 2014 | Unstable Capture Threshold | 1 | Device |
| 2014 | Stretched | 1 | Device |
| 2014 | Signal Artifact/Noise | 1 | Device |
| 2014 | Pocket Stimulation | 1 | Device |
| 2014 | Over-Sensing | 7 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Low impedance | 9 | Device |
| 2014 | Impedance Problem | 1 | Device |
| 2014 | High impedance | 19 | Device |
| 2014 | High Sensing Threshold | 1 | Device |
| 2014 | High Capture Threshold | 15 | Device |
| 2014 | Fracture | 23 | Device |
| 2014 | Failure to Capture | 15 | Device |
| 2014 | Device Sensing Problem | 2 | Device |
| 2014 | Device Dislodged or Dislocated | 1 | Device |
| 2014 | Capturing Problem | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2013 | Insufficient Information | 1 | Patient |
| 2013 | Under-Sensing | 1 | Device |
| 2013 | Shelf Life Exceeded | 1 | Device |
| 2013 | Over-Sensing | 1 | Device |
| 2013 | Mechanical Problem | 1 | Device |
| 2013 | Low impedance | 2 | Device |
| 2013 | Impedance Problem | 1 | Device |
| 2013 | High impedance | 4 | Device |
| 2013 | High Capture Threshold | 1 | Device |
| 2013 | Fracture | 4 | Device |
| 2013 | Failure to Sense | 1 | Device |
| 2013 | Failure to Capture | 3 | Device |
| 2013 | Device Sensing Problem | 1 | Device |
| 2013 | Break | 1 | Device |
| 2012 | High impedance | 1 | Device |
| 2012 | High Capture Threshold | 2 | Device |
| 2012 | Fracture | 1 | Device |
| 2012 | Failure to Capture | 1 | Device |
| 2011 | Fracture | 1 | Device |
| 2009 | Unstable Capture Threshold | 2 | Device |
| 2009 | Positioning Problem | 1 | Device |
| 2009 | Low impedance | 2 | Device |
| 2009 | Intermittent Capture | 2 | Device |
| 2009 | Fracture | 2 | Device |
| 2009 | Failure to Capture | 2 | Device |
| 2009 | Break | 2 | Device |
| 2009 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2008 | Fracture | 1 | Device |
| 2007 | Signal Artifact/Noise | 1 | Device |
| 2007 | Fracture | 1 | Device |
| 2006 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2003 | Fracture | 1 | Device |