DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
This device is manufactured by MEDTRONIC, MEDTRONIC -SWINNEA, MEDTRONIC EUROPE SARL, MEDTRONIC IRELAND, MEDTRONIC MED REL MEDTRONIC PUERTO RICO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 11 | Patient |
| 2024 | Unspecified Tissue Injury | 1 | Patient |
| 2024 | Unspecified Infection | 101 | Patient |
| 2024 | Undesired Nerve Stimulation | 2 | Patient |
| 2024 | Twitching | 2 | Patient |
| 2024 | Twiddlers Syndrome | 11 | Patient |
| 2024 | Tricuspid Valve Insufficiency/ Regurgitation | 2 | Patient |
| 2024 | Thrombosis/Thrombus | 2 | Patient |
| 2024 | Tachycardia | 4 | Patient |
| 2024 | Syncope/Fainting | 12 | Patient |
| 2024 | Swelling/ Edema | 11 | Patient |
| 2024 | Shock from Patient Lead(s) | 2 | Patient |
| 2024 | Septic Shock | 2 | Patient |
| 2024 | Sepsis | 4 | Patient |
| 2024 | Scar Tissue | 1 | Patient |
| 2024 | Purulent Discharge | 18 | Patient |
| 2024 | Pulmonary Embolism | 1 | Patient |
| 2024 | Presyncope | 8 | Patient |
| 2024 | Pocket Erosion | 9 | Patient |
| 2024 | Pneumothorax | 1 | Patient |
| 2024 | Pneumonia | 1 | Patient |
| 2024 | Pleural Effusion | 1 | Patient |
| 2024 | Pericarditis | 2 | Patient |
| 2024 | Pericardial Effusion | 4 | Patient |
| 2024 | Perforation | 2 | Patient |
| 2024 | Pain | 14 | Patient |
| 2024 | Obstruction/Occlusion | 5 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Necrosis | 2 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Myocardial Infarction | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 6 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Insufficient Information | 6 | Patient |
| 2024 | Impaired Healing | 1 | Patient |
| 2024 | Hypoxia | 2 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | Hyperkalemia | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2024 | Hematoma | 3 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 7 | Patient |
| 2024 | Heart Block | 5 | Patient |
| 2024 | Great Vessel Perforation | 1 | Patient |
| 2024 | Fluid Discharge | 3 | Patient |
| 2024 | Fever | 8 | Patient |
| 2024 | Fatigue | 2 | Patient |
| 2024 | Fall | 9 | Patient |
| 2024 | Erythema | 22 | Patient |
| 2024 | Erosion | 9 | Patient |
| 2024 | Endocarditis | 6 | Patient |
| 2024 | Dyspnea | 13 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 4 | Patient |
| 2024 | Dizziness | 19 | Patient |
| 2024 | Discomfort | 17 | Patient |
| 2024 | Device Overstimulation of Tissue | 7 | Patient |
| 2024 | Delirium | 1 | Patient |
| 2024 | Cyst(s) | 2 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Chest Pain | 7 | Patient |
| 2024 | Cardiac Tamponade | 3 | Patient |
| 2024 | Cardiac Perforation | 14 | Patient |
| 2024 | Bruise/Contusion | 1 | Patient |
| 2024 | Bradycardia | 42 | Patient |
| 2024 | Bacterial Infection | 9 | Patient |
| 2024 | Bacteremia | 10 | Patient |
| 2024 | Atrial Fibrillation | 2 | Patient |
| 2024 | Asystole | 7 | Patient |
| 2024 | Aspiration/Inhalation | 1 | Patient |
| 2024 | Arrhythmia | 10 | Patient |
| 2024 | Appropriate Term / Code Not Available | 7 | Patient |
| 2024 | Unstable Capture Threshold | 27 | Device |
| 2024 | Under-Sensing | 75 | Device |
| 2024 | Stretched | 10 | Device |
| 2024 | Signal Artifact/Noise | 16 | Device |
| 2024 | Positioning Problem | 79 | Device |
| 2024 | Positioning Failure | 1 | Device |
| 2024 | Pocket Stimulation | 1 | Device |
| 2024 | Pacing Problem | 43 | Device |
| 2024 | Over-Sensing | 75 | Device |
| 2024 | Mechanical Problem | 4 | Device |
| 2024 | Material Twisted/Bent | 22 | Device |
| 2024 | Material Split, Cut or Torn | 4 | Device |
| 2024 | Material Integrity Problem | 29 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Low impedance | 10 | Device |
| 2024 | Intermittent Capture | 24 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2024 | Impedance Problem | 16 | Device |
| 2024 | High impedance | 30 | Device |
| 2024 | High Capture Threshold | 208 | Device |
| 2024 | Fracture | 10 | Device |
| 2024 | Failure to Capture | 78 | Device |
| 2024 | Electrical /Electronic Property Problem | 4 | Device |
| 2024 | Device Sensing Problem | 15 | Device |
| 2024 | Device Dislodged or Dislocated | 153 | Device |
| 2024 | Device Contamination with Body Fluid | 1 | Device |
| 2024 | Deformation Due to Compressive Stress | 4 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Decreased Sensitivity | 33 | Device |
| 2024 | Capturing Problem | 83 | Device |
| 2024 | Break | 27 | Device |
| 2024 | Appropriate Term/Code Not Available | 26 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 124 | Device |
| 2024 | Activation, Positioning or Separation Problem | 3 | Device |
| 2024 | Accessory Incompatible | 1 | Device |
| 2023 | Wound Dehiscence | 3 | Patient |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Viral Infection | 1 | Patient |
| 2023 | Ventricular Fibrillation | 2 | Patient |
| 2023 | Unspecified Kidney or Urinary Problem | 1 | Patient |
| 2023 | Unspecified Infection | 69 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Twitching | 1 | Patient |
| 2023 | Twiddlers Syndrome | 5 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Taste Disorder | 1 | Patient |
| 2023 | Tachycardia | 12 | Patient |
| 2023 | Syncope/Fainting | 12 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2023 | Swelling/ Edema | 11 | Patient |
| 2023 | Sneezing | 1 | Patient |
| 2023 | Sepsis | 2 | Patient |
| 2023 | Purulent Discharge | 13 | Patient |
| 2023 | Presyncope | 2 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pneumothorax | 2 | Patient |
| 2023 | Pericardial Effusion | 3 | Patient |
| 2023 | Perforation | 6 | Patient |
| 2023 | Pain | 7 | Patient |
| 2023 | Obstruction/Occlusion | 3 | Patient |
| 2023 | Non specific EKG/ECG Changes | 2 | Patient |
| 2023 | Necrosis | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2023 | Loss of consciousness | 2 | Patient |
| 2023 | Ischemia Stroke | 1 | Patient |
| 2023 | Insufficient Information | 6 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Impaired Healing | 1 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Hematoma | 3 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 3 | Patient |
| 2023 | Heart Block | 9 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fistula | 1 | Patient |
| 2023 | Fever | 5 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Erythema | 18 | Patient |
| 2023 | Erosion | 9 | Patient |
| 2023 | Endocarditis | 3 | Patient |
| 2023 | Ectopic Heartbeat | 1 | Patient |
| 2023 | Dyspnea | 6 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Dizziness | 9 | Patient |
| 2023 | Discomfort | 9 | Patient |
| 2023 | Diaphoresis | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 2 | Patient |
| 2023 | Chills | 1 | Patient |
| 2023 | Chest Pain | 10 | Patient |
| 2023 | Cardiogenic Shock | 1 | Patient |
| 2023 | Cardiac Tamponade | 1 | Patient |
| 2023 | Cardiac Perforation | 11 | Patient |
| 2023 | Cardiac Arrest | 4 | Patient |
| 2023 | Bronchospasm | 1 | Patient |
| 2023 | Bradycardia | 20 | Patient |
| 2023 | Bacterial Infection | 11 | Patient |
| 2023 | Bacteremia | 7 | Patient |
| 2023 | Atrial Fibrillation | 2 | Patient |
| 2023 | Asystole | 4 | Patient |
| 2023 | Arrhythmia | 5 | Patient |
| 2023 | Appropriate Term / Code Not Available | 6 | Patient |
| 2023 | Unstable Capture Threshold | 19 | Device |
| 2023 | Under-Sensing | 80 | Device |
| 2023 | Stretched | 8 | Device |
| 2023 | Signal Artifact/Noise | 13 | Device |
| 2023 | Premature Activation | 1 | Device |
| 2023 | Positioning Problem | 52 | Device |
| 2023 | Positioning Failure | 1 | Device |
| 2023 | Pacing Problem | 25 | Device |
| 2023 | Over-Sensing | 52 | Device |
| 2023 | Mechanical Problem | 2 | Device |
| 2023 | Material Twisted/Bent | 14 | Device |
| 2023 | Material Split, Cut or Torn | 2 | Device |
| 2023 | Material Integrity Problem | 12 | Device |
| 2023 | Material Deformation | 2 | Device |
| 2023 | Low impedance | 12 | Device |
| 2023 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2023 | Intermittent Capture | 13 | Device |
| 2023 | Impedance Problem | 21 | Device |
| 2023 | High impedance | 26 | Device |
| 2023 | High Capture Threshold | 152 | Device |
| 2023 | Fracture | 8 | Device |
| 2023 | Failure to Capture | 73 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 7 | Device |
| 2023 | Difficult to Remove | 4 | Device |
| 2023 | Device-Device Incompatibility | 2 | Device |
| 2023 | Device Slipped | 1 | Device |
| 2023 | Device Sensing Problem | 10 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 108 | Device |
| 2023 | Device Contamination with Body Fluid | 2 | Device |
| 2023 | Deformation Due to Compressive Stress | 1 | Device |
| 2023 | Defective Device | 1 | Device |
| 2023 | Decreased Sensitivity | 28 | Device |
| 2023 | Capturing Problem | 39 | Device |
| 2023 | Break | 22 | Device |
| 2023 | Appropriate Term/Code Not Available | 13 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 103 | Device |
| 2023 | Activation, Positioning or Separation Problem | 4 | Device |
| 2022 | Ventricular Fibrillation | 1 | Patient |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Sepsis | 4 | Patient |
| 2022 | Respiratory Failure | 1 | Patient |
| 2022 | Presyncope | 1 | Patient |
| 2022 | Polymyositis | 2 | Patient |
| 2022 | Pocket Erosion | 1 | Patient |
| 2022 | Pneumonia | 1 | Patient |
| 2022 | Pericardial Effusion | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Osteomyelitis | 2 | Patient |
| 2022 | Obstruction/Occlusion | 2 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Cardiac Arrest | 2 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Bacterial Infection | 4 | Patient |
| 2022 | Unstable Capture Threshold | 13 | Device |
| 2022 | Under-Sensing | 31 | Device |
| 2022 | Stretched | 2 | Device |
| 2022 | Signal Artifact/Noise | 6 | Device |
| 2022 | Positioning Problem | 27 | Device |
| 2022 | Pacing Problem | 14 | Device |
| 2022 | Over-Sensing | 44 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Twisted/Bent | 7 | Device |
| 2022 | Material Integrity Problem | 11 | Device |
| 2022 | Low impedance | 2 | Device |
| 2022 | Intermittent Capture | 10 | Device |
| 2022 | Impedance Problem | 10 | Device |
| 2022 | High impedance | 11 | Device |
| 2022 | High Capture Threshold | 123 | Device |
| 2022 | Fracture | 7 | Device |
| 2022 | Failure to Capture | 36 | Device |
| 2022 | Electromagnetic Interference | 2 | Device |
| 2022 | Electrical /Electronic Property Problem | 3 | Device |
| 2022 | Device Sensing Problem | 3 | Device |
| 2022 | Device Handling Problem | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 59 | Device |
| 2022 | Deformation Due to Compressive Stress | 1 | Device |
| 2022 | Decreased Sensitivity | 18 | Device |
| 2022 | Capturing Problem | 28 | Device |
| 2022 | Break | 14 | Device |
| 2022 | Appropriate Term/Code Not Available | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 53 | Device |
| 2022 | Activation, Positioning or Separation Problem | 3 | Device |
| 2022 | Accessory Incompatible | 2 | Device |
| 2021 | Tachycardia | 2 | Patient |
| 2021 | Pericarditis | 1 | Patient |
| 2021 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2021 | Dyspnea | 1 | Patient |
| 2021 | Chest Pain | 1 | Patient |
| 2021 | Cardiac Arrest | 1 | Patient |
| 2021 | Under-Sensing | 1 | Device |
| 2021 | Signal Artifact/Noise | 2 | Device |
| 2021 | Positioning Problem | 1 | Device |
| 2021 | Pacing Problem | 1 | Device |
| 2021 | Over-Sensing | 6 | Device |
| 2021 | Low impedance | 3 | Device |
| 2021 | Intermittent Capture | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Impedance Problem | 2 | Device |
| 2021 | High impedance | 2 | Device |
| 2021 | High Capture Threshold | 13 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Failure to Capture | 6 | Device |
| 2021 | Electrical /Electronic Property Problem | 1 | Device |
| 2021 | Device-Device Incompatibility | 1 | Device |
| 2021 | Device Sensing Problem | 1 | Device |
| 2021 | Device Dislodged or Dislocated | 2 | Device |
| 2021 | Decreased Sensitivity | 1 | Device |
| 2021 | Capturing Problem | 7 | Device |
| 2021 | Break | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Unstable Capture Threshold | 2 | Device |
| 2020 | Under-Sensing | 2 | Device |
| 2020 | Signal Artifact/Noise | 1 | Device |
| 2020 | Over-Sensing | 3 | Device |
| 2020 | Intermittent Capture | 1 | Device |
| 2020 | High Capture Threshold | 4 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Electrical /Electronic Property Problem | 1 | Device |
| 2020 | Device Dislodged or Dislocated | 2 | Device |
| 2020 | Decreased Sensitivity | 3 | Device |
| 2020 | Capturing Problem | 6 | Device |