DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 19 | Patient |
| 2024 | Undesired Nerve Stimulation | 5 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Purulent Discharge | 2 | Patient |
| 2024 | Pneumothorax | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Obstruction/Occlusion | 3 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Fever | 2 | Patient |
| 2024 | Erythema | 1 | Patient |
| 2024 | Erosion | 2 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 6 | Patient |
| 2024 | Bradycardia | 2 | Patient |
| 2024 | Bacteremia | 2 | Patient |
| 2024 | Angioedema | 1 | Patient |
| 2024 | Unstable Capture Threshold | 1 | Device |
| 2024 | Low impedance | 3 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 22 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Failure to Capture | 10 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Handling Problem | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 8 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Capturing Problem | 5 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 25 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Unspecified Infection | 6 | Patient |
| 2023 | Undesired Nerve Stimulation | 2 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Sleep Dysfunction | 1 | Patient |
| 2023 | Pericardial Effusion | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Discomfort | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 4 | Patient |
| 2023 | Chest Pain | 2 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Bacteremia | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | Unstable Capture Threshold | 1 | Device |
| 2023 | Positioning Problem | 2 | Device |
| 2023 | Low impedance | 3 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 4 | Device |
| 2023 | High Capture Threshold | 21 | Device |
| 2023 | Failure to Capture | 6 | Device |
| 2023 | Device Dislodged or Dislocated | 3 | Device |
| 2023 | Device Contamination with Body Fluid | 1 | Device |
| 2023 | Capturing Problem | 5 | Device |
| 2023 | Appropriate Term/Code Not Available | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2023 | Activation, Positioning or Separation Problem | 3 | Device |
| 2022 | Unspecified Infection | 3 | Patient |
| 2022 | Undesired Nerve Stimulation | 1 | Patient |
| 2022 | Twitching | 1 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Cellulitis | 1 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Unstable Capture Threshold | 4 | Device |
| 2022 | Positioning Problem | 2 | Device |
| 2022 | Low impedance | 4 | Device |
| 2022 | Intermittent Capture | 2 | Device |
| 2022 | Impedance Problem | 3 | Device |
| 2022 | High impedance | 3 | Device |
| 2022 | High Capture Threshold | 27 | Device |
| 2022 | Failure to Capture | 6 | Device |
| 2022 | Device-Device Incompatibility | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 4 | Device |
| 2022 | Device Contamination with Body Fluid | 1 | Device |
| 2022 | Capturing Problem | 10 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2022 | Activation, Positioning or Separation Problem | 1 | Device |
| 2021 | Impedance Problem | 2 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | High Capture Threshold | 2 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Capturing Problem | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2020 | Cardiac Perforation | 1 | Patient |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Under-Sensing | 1 | Device |
| 2019 | Positioning Problem | 7 | Device |
| 2019 | Pacing Problem | 2 | Device |
| 2019 | Low impedance | 6 | Device |
| 2019 | Impedance Problem | 7 | Device |
| 2019 | High impedance | 2 | Device |
| 2019 | High Capture Threshold | 20 | Device |
| 2019 | Failure to Sense | 1 | Device |
| 2019 | Failure to Capture | 26 | Device |
| 2019 | Electrical /Electronic Property Problem | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 22 | Device |
| 2019 | Capturing Problem | 14 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 73 | Device |
| 2019 | Activation, Positioning or Separation Problem | 17 | Device |
| 2019 | Accessory Incompatible | 1 | Device |
| 2018 | Syncope/Fainting | 1 | Patient |
| 2018 | Cough | 1 | Patient |
| 2018 | Unstable Capture Threshold | 2 | Device |
| 2018 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2018 | Positioning Problem | 7 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Pacing Problem | 3 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Migration | 1 | Device |
| 2018 | Material Protrusion/Extrusion | 1 | Device |
| 2018 | Material Erosion | 1 | Device |
| 2018 | Low impedance | 8 | Device |
| 2018 | Intermittent Capture | 1 | Device |
| 2018 | Insufficient Information | 4 | Device |
| 2018 | Impedance Problem | 4 | Device |
| 2018 | Human-Device Interface Problem | 1 | Device |
| 2018 | High impedance | 9 | Device |
| 2018 | High Sensing Threshold | 1 | Device |
| 2018 | High Capture Threshold | 33 | Device |
| 2018 | Fracture | 2 | Device |
| 2018 | Failure to Capture | 7 | Device |
| 2018 | Disconnection | 1 | Device |
| 2018 | Difficult to Remove | 2 | Device |
| 2018 | Device Sensing Problem | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 18 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Cut In Material | 1 | Device |
| 2018 | Contamination | 1 | Device |
| 2018 | Connection Problem | 1 | Device |
| 2018 | Complete Blockage | 1 | Device |
| 2018 | Capturing Problem | 19 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 15 | Device |
| 2018 | Application Program Problem | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 92 | Device |
| 2018 | Activation, Positioning or Separation Problem | 15 | Device |
| 2018 | Accessory Incompatible | 2 | Device |
| 2017 | Unstable Capture Threshold | 3 | Device |
| 2017 | Signal Artifact/Noise | 1 | Device |
| 2017 | Positioning Problem | 3 | Device |
| 2017 | Pacing Problem | 3 | Device |
| 2017 | Over-Sensing | 1 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Low impedance | 1 | Device |
| 2017 | Intermittent Capture | 2 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 9 | Device |
| 2017 | High Capture Threshold | 28 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Failure to Capture | 17 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Dislodged or Dislocated | 12 | Device |
| 2017 | Device Contamination with Body Fluid | 1 | Device |
| 2017 | Collapse | 1 | Device |
| 2017 | Capturing Problem | 14 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 32 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2017 | Activation, Positioning or Separation Problem | 12 | Device |
| 2016 | Positioning Problem | 6 | Device |
| 2016 | Low impedance | 2 | Device |
| 2016 | High impedance | 2 | Device |
| 2016 | High Capture Threshold | 10 | Device |
| 2016 | Failure to Capture | 8 | Device |
| 2016 | Device Dislodged or Dislocated | 8 | Device |
| 2016 | Capturing Problem | 2 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Appropriate Term/Code Not Available | 28 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2016 | Activation, Positioning or Separation Problem | 5 | Device |
| 2015 | High Capture Threshold | 1 | Device |
| 2015 | Capturing Problem | 1 | Device |
| 2015 | Appropriate Term/Code Not Available | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2014 | Residue After Decontamination | 1 | Device |
| 2014 | Positioning Problem | 1 | Device |
| 2014 | Mechanical Problem | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |
| 2014 | High impedance | 1 | Device |
| 2014 | High Capture Threshold | 2 | Device |
| 2014 | Device Dislodged or Dislocated | 2 | Device |
| 2014 | Device Contamination with Body Fluid | 1 | Device |
| 2014 | Activation, Positioning or Separation Problem | 2 | Device |
| 2013 | Positioning Problem | 2 | Device |
| 2013 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2013 | Capturing Problem | 1 | Device |
| 2013 | Activation, Positioning or Separation Problem | 1 | Device |