ELECTRODE, PACEMAKER, PERMANENT
This device is manufactured by MDT PUERTO RICO OPERATIONS CO MED REL, MDT SOFAMOR DANEK PUERTO RICO MFG, MEDTRONIC, MEDTRONIC -SWINNEA, MEDTRONIC EUROPE SARL and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 27 | Patient |
| 2024 | Vomiting | 1 | Patient |
| 2024 | Ventricular Fibrillation | 5 | Patient |
| 2024 | Unspecified Infection | 442 | Patient |
| 2024 | Undesired Nerve Stimulation | 9 | Patient |
| 2024 | Twitching | 1 | Patient |
| 2024 | Twiddlers Syndrome | 14 | Patient |
| 2024 | Tricuspid Valve Insufficiency/ Regurgitation | 3 | Patient |
| 2024 | Thrombosis/Thrombus | 10 | Patient |
| 2024 | Tachycardia | 32 | Patient |
| 2024 | Syncope/Fainting | 73 | Patient |
| 2024 | Swelling/ Edema | 38 | Patient |
| 2024 | Stroke/CVA | 2 | Patient |
| 2024 | Stenosis | 2 | Patient |
| 2024 | Shock from Patient Lead(s) | 12 | Patient |
| 2024 | Septic Shock | 6 | Patient |
| 2024 | Sepsis | 52 | Patient |
| 2024 | Respiratory Failure | 2 | Patient |
| 2024 | Renal Impairment | 1 | Patient |
| 2024 | Renal Failure | 3 | Patient |
| 2024 | Rash | 4 | Patient |
| 2024 | Purulent Discharge | 53 | Patient |
| 2024 | Pulmonary Emphysema | 1 | Patient |
| 2024 | Presyncope | 22 | Patient |
| 2024 | Pressure Sores | 2 | Patient |
| 2024 | Post Operative Wound Infection | 3 | Patient |
| 2024 | Pocket Erosion | 37 | Patient |
| 2024 | Pneumothorax | 7 | Patient |
| 2024 | Pneumonia | 2 | Patient |
| 2024 | Pleural Effusion | 4 | Patient |
| 2024 | Pericarditis | 3 | Patient |
| 2024 | Pericardial Effusion | 42 | Patient |
| 2024 | Perforation | 13 | Patient |
| 2024 | Pallor | 1 | Patient |
| 2024 | Pain | 56 | Patient |
| 2024 | Obstruction/Occlusion | 21 | Patient |
| 2024 | Numbness | 1 | Patient |
| 2024 | Non specific EKG/ECG Changes | 5 | Patient |
| 2024 | Necrosis | 5 | Patient |
| 2024 | Nausea | 5 | Patient |
| 2024 | Muscle Weakness/Atrophy | 32 | Patient |
| 2024 | Low Oxygen Saturation | 2 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 17 | Patient |
| 2024 | Loss of consciousness | 4 | Patient |
| 2024 | Lethargy | 3 | Patient |
| 2024 | Itching Sensation | 3 | Patient |
| 2024 | Insufficient Information | 23 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Impaired Healing | 6 | Patient |
| 2024 | Hypoxia | 3 | Patient |
| 2024 | Hypovolemia | 1 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 8 | Patient |
| 2024 | Hyperkalemia | 2 | Patient |
| 2024 | High Blood Pressure/ Hypertension | 6 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Hematuria | 1 | Patient |
| 2024 | Hematoma | 6 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 14 | Patient |
| 2024 | Heart Block | 16 | Patient |
| 2024 | Great Vessel Perforation | 2 | Patient |
| 2024 | Fungal Infection | 4 | Patient |
| 2024 | Fluid Discharge | 5 | Patient |
| 2024 | Fever | 41 | Patient |
| 2024 | Fatigue | 8 | Patient |
| 2024 | Fall | 25 | Patient |
| 2024 | Failure of Implant | 2 | Patient |
| 2024 | Erythema | 77 | Patient |
| 2024 | Erosion | 46 | Patient |
| 2024 | Endocarditis | 16 | Patient |
| 2024 | Embolism/Embolus | 1 | Patient |
| 2024 | Dyspnea | 82 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 13 | Patient |
| 2024 | Dizziness | 79 | Patient |
| 2024 | Discomfort | 75 | Patient |
| 2024 | Diminished Pulse Pressure | 1 | Patient |
| 2024 | Diarrhea | 1 | Patient |
| 2024 | Diaphoresis | 2 | Patient |
| 2024 | Device Overstimulation of Tissue | 22 | Patient |
| 2024 | Delirium | 1 | Patient |
| 2024 | Confusion/ Disorientation | 1 | Patient |
| 2024 | Chest Pain | 93 | Patient |
| 2024 | Cellulitis | 3 | Patient |
| 2024 | Cardiovascular Insufficiency | 1 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Cardiac Tamponade | 11 | Patient |
| 2024 | Cardiac Perforation | 37 | Patient |
| 2024 | Cardiac Arrest | 17 | Patient |
| 2024 | Bruise/Contusion | 2 | Patient |
| 2024 | Bradycardia | 78 | Patient |
| 2024 | Bone Fracture(s) | 1 | Patient |
| 2024 | Bacterial Infection | 61 | Patient |
| 2024 | Bacteremia | 57 | Patient |
| 2024 | Atrial Fibrillation | 22 | Patient |
| 2024 | Asystole | 12 | Patient |
| 2024 | Arteriosclerosis/ Atherosclerosis | 1 | Patient |
| 2024 | Arrhythmia | 62 | Patient |
| 2024 | Appropriate Term / Code Not Available | 18 | Patient |
| 2024 | Aortic Valve Stenosis | 2 | Patient |
| 2024 | Angioedema | 1 | Patient |
| 2024 | Angina | 1 | Patient |
| 2024 | Altered State of Consciousness | 2 | Patient |
| 2024 | Abscess | 4 | Patient |
| 2024 | Abdominal Pain | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Unstable Capture Threshold | 63 | Device |
| 2024 | Under-Sensing | 1183 | Device |
| 2024 | Stretched | 2 | Device |
| 2024 | Signal Artifact/Noise | 224 | Device |
| 2024 | Premature Activation | 4 | Device |
| 2024 | Positioning Problem | 93 | Device |
| 2024 | Positioning Failure | 19 | Device |
| 2024 | Pocket Stimulation | 1 | Device |
| 2024 | Pacing Problem | 314 | Device |
| 2024 | Over-Sensing | 630 | Device |
| 2024 | Obstruction of Flow | 1 | Device |
| 2024 | Naturally Worn | 1 | Device |
| 2024 | Mechanical Problem | 11 | Device |
| 2024 | Material Twisted/Bent | 12 | Device |
| 2024 | Material Split, Cut or Torn | 2 | Device |
| 2024 | Material Separation | 1 | Device |
| 2024 | Material Integrity Problem | 40 | Device |
| 2024 | Low impedance | 79 | Device |
| 2024 | Loose or Intermittent Connection | 5 | Device |
| 2024 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2024 | Intermittent Capture | 37 | Device |
| 2024 | Insufficient Information | 6 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2024 | Impedance Problem | 185 | Device |
| 2024 | High impedance | 285 | Device |
| 2024 | High Capture Threshold | 439 | Device |
| 2024 | Fracture | 150 | Device |
| 2024 | Failure to Capture | 172 | Device |
| 2024 | Electromagnetic Interference | 2 | Device |
| 2024 | Electrical /Electronic Property Problem | 144 | Device |
| 2024 | Disconnection | 1 | Device |
| 2024 | Difficult to Remove | 3 | Device |
| 2024 | Device-Device Incompatibility | 5 | Device |
| 2024 | Device Slipped | 1 | Device |
| 2024 | Device Sensing Problem | 57 | Device |
| 2024 | Device Handling Problem | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 274 | Device |
| 2024 | Device Contamination with Body Fluid | 1 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Deformation Due to Compressive Stress | 2 | Device |
| 2024 | Defibrillation/Stimulation Problem | 1 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Decreased Sensitivity | 180 | Device |
| 2024 | Crack | 1 | Device |
| 2024 | Connection Problem | 6 | Device |
| 2024 | Collapse | 4 | Device |
| 2024 | Capturing Problem | 132 | Device |
| 2024 | Break | 63 | Device |
| 2024 | Appropriate Term/Code Not Available | 51 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 537 | Device |
| 2024 | Activation, Positioning or Separation Problem | 71 | Device |
| 2023 | Wound Dehiscence | 20 | Patient |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Viral Infection | 1 | Patient |
| 2023 | Ventricular Fibrillation | 4 | Patient |
| 2023 | Vascular Dissection | 1 | Patient |
| 2023 | Unspecified Infection | 308 | Patient |
| 2023 | Undesired Nerve Stimulation | 8 | Patient |
| 2023 | Twitching | 3 | Patient |
| 2023 | Twiddlers Syndrome | 4 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 5 | Patient |
| 2023 | Transient Ischemic Attack | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Taste Disorder | 1 | Patient |
| 2023 | Tachycardia | 26 | Patient |
| 2023 | Syncope/Fainting | 54 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2023 | Swelling/ Edema | 27 | Patient |
| 2023 | Stroke/CVA | 3 | Patient |
| 2023 | Sneezing | 1 | Patient |
| 2023 | Sleep Dysfunction | 1 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Skin Erosion | 2 | Patient |
| 2023 | Shock from Patient Lead(s) | 7 | Patient |
| 2023 | Shock | 1 | Patient |
| 2023 | Shaking/Tremors | 1 | Patient |
| 2023 | Septic Shock | 5 | Patient |
| 2023 | Sepsis | 25 | Patient |
| 2023 | Respiratory Insufficiency | 1 | Patient |
| 2023 | Purulent Discharge | 27 | Patient |
| 2023 | Pulmonary Embolism | 1 | Patient |
| 2023 | Presyncope | 14 | Patient |
| 2023 | Pocket Erosion | 29 | Patient |
| 2023 | Pneumothorax | 2 | Patient |
| 2023 | Pneumonia | 3 | Patient |
| 2023 | Pericardial Effusion | 29 | Patient |
| 2023 | Perforation of Vessels | 2 | Patient |
| 2023 | Perforation | 13 | Patient |
| 2023 | Pain | 35 | Patient |
| 2023 | Obstruction/Occlusion | 24 | Patient |
| 2023 | Non specific EKG/ECG Changes | 16 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Myocardial Infarction | 2 | Patient |
| 2023 | Muscle Weakness/Atrophy | 19 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 9 | Patient |
| 2023 | Loss of consciousness | 5 | Patient |
| 2023 | Lethargy | 1 | Patient |
| 2023 | Itching Sensation | 2 | Patient |
| 2023 | Ischemic Heart Disease | 1 | Patient |
| 2023 | Ischemia Stroke | 1 | Patient |
| 2023 | Insufficient Information | 28 | Patient |
| 2023 | Inflammation | 2 | Patient |
| 2023 | Impaired Healing | 6 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 2 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 2 | Patient |
| 2023 | Hemothorax | 2 | Patient |
| 2023 | Hematoma | 6 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 5 | Patient |
| 2023 | Heart Block | 12 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Gastrointestinal Hemorrhage | 1 | Patient |
| 2023 | Fluid Discharge | 10 | Patient |
| 2023 | Fistula | 2 | Patient |
| 2023 | Fever | 12 | Patient |
| 2023 | Fatigue | 18 | Patient |
| 2023 | Fall | 19 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Erythema | 31 | Patient |
| 2023 | Erosion | 28 | Patient |
| 2023 | Endocarditis | 18 | Patient |
| 2023 | Dyspnea | 66 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 9 | Patient |
| 2023 | Dizziness | 54 | Patient |
| 2023 | Distress | 1 | Patient |
| 2023 | Discomfort | 34 | Patient |
| 2023 | Diaphoresis | 3 | Patient |
| 2023 | Device Overstimulation of Tissue | 18 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 4 | Patient |
| 2023 | Cough | 1 | Patient |
| 2023 | Cognitive Changes | 1 | Patient |
| 2023 | Chills | 2 | Patient |
| 2023 | Chest Pain | 78 | Patient |
| 2023 | Cardiogenic Shock | 2 | Patient |
| 2023 | Cardiac Tamponade | 15 | Patient |
| 2023 | Cardiac Perforation | 27 | Patient |
| 2023 | Cardiac Arrest | 11 | Patient |
| 2023 | Burning Sensation | 2 | Patient |
| 2023 | Bradycardia | 51 | Patient |
| 2023 | Bone Fracture(s) | 1 | Patient |
| 2023 | Bacterial Infection | 40 | Patient |
| 2023 | Bacteremia | 24 | Patient |
| 2023 | Atrial Flutter | 8 | Patient |
| 2023 | Atrial Fibrillation | 15 | Patient |
| 2023 | Asystole | 9 | Patient |
| 2023 | Aspiration/Inhalation | 1 | Patient |
| 2023 | Arrhythmia | 43 | Patient |
| 2023 | Appropriate Term / Code Not Available | 34 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Alteration in Body Temperature | 1 | Patient |
| 2023 | Abdominal Pain | 1 | Patient |
| 2023 | Abdominal Distention | 1 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unstable Capture Threshold | 45 | Device |
| 2023 | Under-Sensing | 1791 | Device |
| 2023 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2023 | Stretched | 1 | Device |
| 2023 | Signal Artifact/Noise | 190 | Device |
| 2023 | Premature Activation | 9 | Device |
| 2023 | Positioning Problem | 76 | Device |
| 2023 | Positioning Failure | 21 | Device |
| 2023 | Pocket Stimulation | 6 | Device |
| 2023 | Pacing Problem | 147 | Device |
| 2023 | Over-Sensing | 611 | Device |
| 2023 | Mechanical Problem | 7 | Device |
| 2023 | Material Twisted/Bent | 11 | Device |
| 2023 | Material Integrity Problem | 23 | Device |
| 2023 | Low impedance | 126 | Device |
| 2023 | Intermittent Capture | 27 | Device |
| 2023 | Insufficient Information | 4 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2023 | Impedance Problem | 159 | Device |
| 2023 | High impedance | 279 | Device |
| 2023 | High Capture Threshold | 470 | Device |
| 2023 | Fracture | 136 | Device |
| 2023 | Failure to Capture | 210 | Device |
| 2023 | Electromagnetic Interference | 2 | Device |
| 2023 | Electrical /Electronic Property Problem | 157 | Device |
| 2023 | Disconnection | 1 | Device |
| 2023 | Difficult to Remove | 2 | Device |
| 2023 | Device-Device Incompatibility | 2 | Device |
| 2023 | Device Sensing Problem | 37 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 265 | Device |
| 2023 | Device Contamination with Body Fluid | 1 | Device |
| 2023 | Deformation Due to Compressive Stress | 4 | Device |
| 2023 | Decreased Sensitivity | 172 | Device |
| 2023 | Connection Problem | 6 | Device |
| 2023 | Collapse | 4 | Device |
| 2023 | Coagulation in Device or Device Ingredient | 2 | Device |
| 2023 | Capturing Problem | 119 | Device |
| 2023 | Break | 45 | Device |
| 2023 | Appropriate Term/Code Not Available | 51 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 464 | Device |
| 2023 | Activation, Positioning or Separation Problem | 63 | Device |
| 2022 | Wound Dehiscence | 1 | Patient |
| 2022 | Ventricular Fibrillation | 1 | Patient |
| 2022 | Unspecified Infection | 33 | Patient |
| 2022 | Twiddlers Syndrome | 4 | Patient |
| 2022 | Thrombosis/Thrombus | 2 | Patient |
| 2022 | Tachycardia | 7 | Patient |
| 2022 | Syncope/Fainting | 11 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Sepsis | 5 | Patient |
| 2022 | Respiratory Acidosis | 1 | Patient |
| 2022 | Presyncope | 5 | Patient |
| 2022 | Pocket Erosion | 3 | Patient |
| 2022 | Pneumothorax | 3 | Patient |
| 2022 | Pleural Effusion | 3 | Patient |
| 2022 | Pericardial Effusion | 6 | Patient |
| 2022 | Perforation | 4 | Patient |
| 2022 | Pain | 3 | Patient |
| 2022 | Obstruction/Occlusion | 8 | Patient |
| 2022 | Non specific EKG/ECG Changes | 4 | Patient |
| 2022 | Nausea | 1 | Patient |
| 2022 | Muscle Weakness/Atrophy | 7 | Patient |
| 2022 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2022 | Loss of consciousness | 4 | Patient |
| 2022 | Insufficient Information | 12 | Patient |
| 2022 | Hypoxia | 2 | Patient |
| 2022 | Hemothorax | 1 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2022 | Heart Block | 5 | Patient |
| 2022 | Fall | 4 | Patient |
| 2022 | Endocarditis | 3 | Patient |
| 2022 | Dyspnea | 18 | Patient |
| 2022 | Drug Resistant Bacterial Infection | 5 | Patient |
| 2022 | Dizziness | 14 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Device Overstimulation of Tissue | 5 | Patient |
| 2022 | Convulsion/Seizure | 1 | Patient |
| 2022 | Chest Pain | 24 | Patient |
| 2022 | Cellulitis | 2 | Patient |
| 2022 | Cardiomyopathy | 1 | Patient |
| 2022 | Cardiogenic Shock | 1 | Patient |
| 2022 | Cardiac Tamponade | 4 | Patient |
| 2022 | Cardiac Perforation | 6 | Patient |
| 2022 | Cardiac Arrest | 3 | Patient |
| 2022 | Calcium Deposits/Calcification | 1 | Patient |
| 2022 | Burning Sensation | 1 | Patient |
| 2022 | Bradycardia | 14 | Patient |
| 2022 | Blurred Vision | 1 | Patient |
| 2022 | Bacterial Infection | 11 | Patient |
| 2022 | Atrial Fibrillation | 4 | Patient |
| 2022 | Asystole | 5 | Patient |
| 2022 | Arrhythmia | 12 | Patient |
| 2022 | Appropriate Term / Code Not Available | 4 | Patient |
| 2022 | Abdominal Pain | 1 | Patient |
| 2022 | Unstable Capture Threshold | 55 | Device |
| 2022 | Under-Sensing | 866 | Device |
| 2022 | Stretched | 1 | Device |
| 2022 | Signal Artifact/Noise | 132 | Device |
| 2022 | Positioning Problem | 69 | Device |
| 2022 | Positioning Failure | 11 | Device |
| 2022 | Pocket Stimulation | 2 | Device |
| 2022 | Pacing Problem | 105 | Device |
| 2022 | Over-Sensing | 433 | Device |
| 2022 | Mechanical Problem | 4 | Device |
| 2022 | Material Twisted/Bent | 6 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Integrity Problem | 23 | Device |
| 2022 | Low impedance | 106 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2022 | Intermittent Capture | 26 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Impedance Problem | 145 | Device |
| 2022 | Human-Device Interface Problem | 1 | Device |
| 2022 | High impedance | 196 | Device |
| 2022 | High Capture Threshold | 354 | Device |
| 2022 | Fracture | 92 | Device |
| 2022 | Failure to Capture | 172 | Device |
| 2022 | Expiration Date Error | 1 | Device |
| 2022 | Electromagnetic Interference | 4 | Device |
| 2022 | Electrical /Electronic Property Problem | 134 | Device |
| 2022 | Disconnection | 2 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Device-Device Incompatibility | 1 | Device |
| 2022 | Device Sensing Problem | 37 | Device |
| 2022 | Device Dislodged or Dislocated | 242 | Device |
| 2022 | Degraded | 2 | Device |
| 2022 | Deformation Due to Compressive Stress | 1 | Device |
| 2022 | Decreased Sensitivity | 149 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Component Missing | 2 | Device |
| 2022 | Collapse | 6 | Device |
| 2022 | Capturing Problem | 83 | Device |
| 2022 | Break | 33 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 39 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 413 | Device |
| 2022 | Activation, Positioning or Separation Problem | 32 | Device |
| 2021 | Ventricular Fibrillation | 2 | Patient |
| 2021 | Unspecified Infection | 13 | Patient |
| 2021 | Undesired Nerve Stimulation | 1 | Patient |
| 2021 | Tachycardia | 3 | Patient |
| 2021 | Syncope/Fainting | 1 | Patient |
| 2021 | Swelling/ Edema | 1 | Patient |
| 2021 | Septic Shock | 1 | Patient |
| 2021 | Sepsis | 3 | Patient |
| 2021 | Pneumonia | 2 | Patient |
| 2021 | Pericarditis | 1 | Patient |
| 2021 | Pericardial Effusion | 1 | Patient |
| 2021 | Pain | 1 | Patient |
| 2021 | Obstruction/Occlusion | 2 | Patient |
| 2021 | Non specific EKG/ECG Changes | 2 | Patient |
| 2021 | Muscle Weakness/Atrophy | 1 | Patient |
| 2021 | Insufficient Information | 4 | Patient |
| 2021 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2021 | Hematoma | 2 | Patient |
| 2021 | Fever | 2 | Patient |
| 2021 | Fall | 1 | Patient |
| 2021 | Dyspnea | 4 | Patient |
| 2021 | Device Overstimulation of Tissue | 1 | Patient |
| 2021 | Chest Pain | 3 | Patient |
| 2021 | Cardiac Arrest | 4 | Patient |
| 2021 | Calcium Deposits/Calcification | 1 | Patient |
| 2021 | Bacterial Infection | 7 | Patient |
| 2021 | Bacteremia | 3 | Patient |
| 2021 | Atrial Fibrillation | 1 | Patient |
| 2021 | Arrhythmia | 4 | Patient |
| 2021 | Appropriate Term / Code Not Available | 2 | Patient |
| 2021 | Adhesion(s) | 3 | Patient |
| 2021 | Unstable Capture Threshold | 3 | Device |
| 2021 | Under-Sensing | 74 | Device |
| 2021 | Signal Artifact/Noise | 20 | Device |
| 2021 | Positioning Problem | 2 | Device |
| 2021 | Pacing Problem | 9 | Device |
| 2021 | Over-Sensing | 69 | Device |
| 2021 | Material Split, Cut or Torn | 2 | Device |
| 2021 | Low impedance | 27 | Device |
| 2021 | Intermittent Capture | 1 | Device |
| 2021 | Insufficient Information | 3 | Device |
| 2021 | Impedance Problem | 25 | Device |
| 2021 | High impedance | 29 | Device |
| 2021 | High Sensing Threshold | 1 | Device |
| 2021 | High Capture Threshold | 54 | Device |
| 2021 | Fracture | 9 | Device |
| 2021 | Failure to Capture | 15 | Device |
| 2021 | Electromagnetic Interference | 1 | Device |
| 2021 | Electrical /Electronic Property Problem | 39 | Device |
| 2021 | Device-Device Incompatibility | 2 | Device |
| 2021 | Device Sensing Problem | 4 | Device |
| 2021 | Device Dislodged or Dislocated | 7 | Device |
| 2021 | Decreased Sensitivity | 11 | Device |
| 2021 | Connection Problem | 1 | Device |
| 2021 | Capturing Problem | 10 | Device |
| 2021 | Break | 2 | Device |
| 2021 | Appropriate Term/Code Not Available | 5 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 33 | Device |
| 2020 | Obstruction/Occlusion | 2 | Patient |
| 2020 | Muscle Weakness/Atrophy | 2 | Patient |
| 2020 | Insufficient Information | 2 | Patient |
| 2020 | Chest Pain | 1 | Patient |
| 2020 | Bradycardia | 1 | Patient |
| 2020 | Arrhythmia | 1 | Patient |
| 2020 | Under-Sensing | 18 | Device |
| 2020 | Signal Artifact/Noise | 7 | Device |
| 2020 | Positioning Problem | 1 | Device |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Over-Sensing | 24 | Device |
| 2020 | Material Integrity Problem | 2 | Device |
| 2020 | Low impedance | 9 | Device |
| 2020 | Impedance Problem | 9 | Device |
| 2020 | High impedance | 12 | Device |
| 2020 | High Capture Threshold | 15 | Device |
| 2020 | Fracture | 3 | Device |
| 2020 | Failure to Capture | 6 | Device |
| 2020 | Electrical /Electronic Property Problem | 10 | Device |
| 2020 | Device Dislodged or Dislocated | 5 | Device |
| 2020 | Degraded | 1 | Device |
| 2020 | Decreased Sensitivity | 2 | Device |
| 2020 | Capturing Problem | 4 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 3 | Device |