DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
This device is manufactured by MEDTRONIC EUROPE SARL, MEDTRONIC PUERTO RICO OPERATIONS CO, MEDTRONIC SINGAPORE OPERATIONS, RICE CREEK MFG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 7 | Patient |
| 2024 | Ventricular Fibrillation | 9 | Patient |
| 2024 | Vascular Dissection | 1 | Patient |
| 2024 | Unspecified Nervous System Problem | 1 | Patient |
| 2024 | Unspecified Infection | 86 | Patient |
| 2024 | Undesired Nerve Stimulation | 3 | Patient |
| 2024 | Twitching | 1 | Patient |
| 2024 | Twiddlers Syndrome | 3 | Patient |
| 2024 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 2 | Patient |
| 2024 | Tachycardia | 5 | Patient |
| 2024 | Syncope/Fainting | 16 | Patient |
| 2024 | Swelling/ Edema | 7 | Patient |
| 2024 | Shock from Patient Lead(s) | 36 | Patient |
| 2024 | Septic Shock | 1 | Patient |
| 2024 | Sepsis | 5 | Patient |
| 2024 | Respiratory Insufficiency | 2 | Patient |
| 2024 | Renal Failure | 1 | Patient |
| 2024 | Purulent Discharge | 13 | Patient |
| 2024 | Pulmonary Embolism | 1 | Patient |
| 2024 | Presyncope | 3 | Patient |
| 2024 | Pocket Erosion | 4 | Patient |
| 2024 | Pneumothorax | 1 | Patient |
| 2024 | Pneumonia | 2 | Patient |
| 2024 | Pleural Effusion | 1 | Patient |
| 2024 | Pericarditis | 1 | Patient |
| 2024 | Pericardial Effusion | 9 | Patient |
| 2024 | Perforation | 2 | Patient |
| 2024 | Pain | 11 | Patient |
| 2024 | Obstruction/Occlusion | 3 | Patient |
| 2024 | Non specific EKG/ECG Changes | 3 | Patient |
| 2024 | Neck Pain | 1 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 4 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Intracranial Hemorrhage | 1 | Patient |
| 2024 | Insufficient Information | 11 | Patient |
| 2024 | Impaired Healing | 1 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Hypovolemia | 1 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 2 | Patient |
| 2024 | Hyperkalemia | 2 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Hematoma | 2 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Headache | 1 | Patient |
| 2024 | Great Vessel Perforation | 1 | Patient |
| 2024 | Fever | 6 | Patient |
| 2024 | Fatigue | 2 | Patient |
| 2024 | Fall | 5 | Patient |
| 2024 | Exsanguination | 1 | Patient |
| 2024 | Erythema | 11 | Patient |
| 2024 | Erosion | 7 | Patient |
| 2024 | Endocarditis | 8 | Patient |
| 2024 | Dyspnea | 10 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 3 | Patient |
| 2024 | Dizziness | 10 | Patient |
| 2024 | Discomfort | 15 | Patient |
| 2024 | Device Overstimulation of Tissue | 3 | Patient |
| 2024 | Chest Pain | 14 | Patient |
| 2024 | Cellulitis | 1 | Patient |
| 2024 | Cardiovascular Insufficiency | 1 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Cardiac Tamponade | 4 | Patient |
| 2024 | Cardiac Perforation | 6 | Patient |
| 2024 | Cardiac Arrest | 7 | Patient |
| 2024 | Brain Injury | 1 | Patient |
| 2024 | Bradycardia | 8 | Patient |
| 2024 | Bacterial Infection | 13 | Patient |
| 2024 | Bacteremia | 19 | Patient |
| 2024 | Asystole | 4 | Patient |
| 2024 | Arrhythmia | 3 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Anemia | 2 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Unstable Capture Threshold | 8 | Device |
| 2024 | Under-Sensing | 79 | Device |
| 2024 | Signal Artifact/Noise | 64 | Device |
| 2024 | Premature Activation | 3 | Device |
| 2024 | Positioning Problem | 15 | Device |
| 2024 | Positioning Failure | 4 | Device |
| 2024 | Pacing Problem | 13 | Device |
| 2024 | Over-Sensing | 231 | Device |
| 2024 | Mechanical Problem | 6 | Device |
| 2024 | Material Twisted/Bent | 3 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Separation | 1 | Device |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Material Discolored | 1 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Low impedance | 39 | Device |
| 2024 | Intermittent Capture | 4 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 29 | Device |
| 2024 | Impedance Problem | 75 | Device |
| 2024 | High impedance | 106 | Device |
| 2024 | High Capture Threshold | 59 | Device |
| 2024 | Fracture | 77 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2024 | Failure to Capture | 28 | Device |
| 2024 | Electrical /Electronic Property Problem | 2 | Device |
| 2024 | Device-Device Incompatibility | 2 | Device |
| 2024 | Device Sensing Problem | 8 | Device |
| 2024 | Device Dislodged or Dislocated | 17 | Device |
| 2024 | Device Contamination with Body Fluid | 2 | Device |
| 2024 | Deformation Due to Compressive Stress | 1 | Device |
| 2024 | Decreased Sensitivity | 38 | Device |
| 2024 | Contamination | 1 | Device |
| 2024 | Connection Problem | 3 | Device |
| 2024 | Collapse | 2 | Device |
| 2024 | Capturing Problem | 16 | Device |
| 2024 | Break | 7 | Device |
| 2024 | Appropriate Term/Code Not Available | 19 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 92 | Device |
| 2024 | Activation, Positioning or Separation Problem | 15 | Device |
| 2024 | Accessory Incompatible | 1 | Device |
| 2023 | Wound Dehiscence | 7 | Patient |
| 2023 | Ventricular Fibrillation | 10 | Patient |
| 2023 | Unspecified Infection | 116 | Patient |
| 2023 | Twitching | 1 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 2 | Patient |
| 2023 | Tachycardia | 8 | Patient |
| 2023 | Syncope/Fainting | 20 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 2 | Patient |
| 2023 | Swelling/ Edema | 8 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Stenosis | 1 | Patient |
| 2023 | Skin Inflammation/ Irritation | 2 | Patient |
| 2023 | Skin Discoloration | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 44 | Patient |
| 2023 | Septic Shock | 2 | Patient |
| 2023 | Sepsis | 16 | Patient |
| 2023 | Respiratory Insufficiency | 1 | Patient |
| 2023 | Purulent Discharge | 17 | Patient |
| 2023 | Pulmonary Embolism | 1 | Patient |
| 2023 | Presyncope | 5 | Patient |
| 2023 | Pocket Erosion | 10 | Patient |
| 2023 | Pneumothorax | 2 | Patient |
| 2023 | Pleural Effusion | 1 | Patient |
| 2023 | Pericardial Effusion | 7 | Patient |
| 2023 | Perforation | 1 | Patient |
| 2023 | Pain | 10 | Patient |
| 2023 | Obstruction/Occlusion | 7 | Patient |
| 2023 | Non specific EKG/ECG Changes | 2 | Patient |
| 2023 | Nipple Ulceration | 1 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 5 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2023 | Loss of consciousness | 1 | Patient |
| 2023 | Insufficient Information | 10 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Idioventricular Rhythm | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Hematoma | 3 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2023 | Heart Block | 4 | Patient |
| 2023 | Gastrointestinal Hemorrhage | 1 | Patient |
| 2023 | Fluid Discharge | 4 | Patient |
| 2023 | Fistula | 2 | Patient |
| 2023 | Fever | 11 | Patient |
| 2023 | Fatigue | 3 | Patient |
| 2023 | Fall | 3 | Patient |
| 2023 | Erythema | 15 | Patient |
| 2023 | Erosion | 5 | Patient |
| 2023 | Endocarditis | 4 | Patient |
| 2023 | Dyspnea | 11 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 5 | Patient |
| 2023 | Dizziness | 8 | Patient |
| 2023 | Discomfort | 18 | Patient |
| 2023 | Diaphoresis | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Cough | 2 | Patient |
| 2023 | Chills | 1 | Patient |
| 2023 | Chest Pain | 12 | Patient |
| 2023 | Cellulitis | 1 | Patient |
| 2023 | Cardiac Tamponade | 5 | Patient |
| 2023 | Cardiac Perforation | 6 | Patient |
| 2023 | Cardiac Arrest | 7 | Patient |
| 2023 | Bradycardia | 11 | Patient |
| 2023 | Bacterial Infection | 15 | Patient |
| 2023 | Bacteremia | 15 | Patient |
| 2023 | Atrial Fibrillation | 2 | Patient |
| 2023 | Asystole | 5 | Patient |
| 2023 | Arrhythmia | 3 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Angina | 1 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Unstable Capture Threshold | 18 | Device |
| 2023 | Under-Sensing | 110 | Device |
| 2023 | Stretched | 1 | Device |
| 2023 | Signal Artifact/Noise | 132 | Device |
| 2023 | Protective Measures Problem | 1 | Device |
| 2023 | Premature Activation | 5 | Device |
| 2023 | Positioning Problem | 19 | Device |
| 2023 | Positioning Failure | 15 | Device |
| 2023 | Pacing Problem | 29 | Device |
| 2023 | Over-Sensing | 412 | Device |
| 2023 | Naturally Worn | 1 | Device |
| 2023 | Mechanical Problem | 13 | Device |
| 2023 | Material Twisted/Bent | 6 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Integrity Problem | 7 | Device |
| 2023 | Low impedance | 67 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2023 | Intermittent Capture | 2 | Device |
| 2023 | Insufficient Information | 3 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 43 | Device |
| 2023 | Impedance Problem | 140 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | High impedance | 176 | Device |
| 2023 | High Capture Threshold | 114 | Device |
| 2023 | Fracture | 126 | Device |
| 2023 | Failure to Convert Rhythm | 1 | Device |
| 2023 | Failure to Capture | 35 | Device |
| 2023 | Electromagnetic Interference | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 4 | Device |
| 2023 | Difficult to Remove | 2 | Device |
| 2023 | Device-Device Incompatibility | 2 | Device |
| 2023 | Device Sensing Problem | 11 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 50 | Device |
| 2023 | Device Contamination with Body Fluid | 2 | Device |
| 2023 | Defibrillation/Stimulation Problem | 1 | Device |
| 2023 | Decreased Sensitivity | 84 | Device |
| 2023 | Connection Problem | 3 | Device |
| 2023 | Collapse | 2 | Device |
| 2023 | Capturing Problem | 44 | Device |
| 2023 | Break | 13 | Device |
| 2023 | Appropriate Term/Code Not Available | 18 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 161 | Device |
| 2023 | Activation, Positioning or Separation Problem | 19 | Device |
| 2023 | Accessory Incompatible | 1 | Device |
| 2022 | Unspecified Infection | 11 | Patient |
| 2022 | Twiddlers Syndrome | 3 | Patient |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Shock from Patient Lead(s) | 4 | Patient |
| 2022 | Sepsis | 2 | Patient |
| 2022 | Pericardial Effusion | 2 | Patient |
| 2022 | Perforation | 1 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Muscle Weakness/Atrophy | 2 | Patient |
| 2022 | Low Cardiac Output | 1 | Patient |
| 2022 | Ischemic Heart Disease | 1 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2022 | Heart Block | 1 | Patient |
| 2022 | Endocarditis | 1 | Patient |
| 2022 | Dyspnea | 3 | Patient |
| 2022 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2022 | Dizziness | 2 | Patient |
| 2022 | Distress | 2 | Patient |
| 2022 | Chest Pain | 3 | Patient |
| 2022 | Cardiomyopathy | 1 | Patient |
| 2022 | Cardiac Arrest | 1 | Patient |
| 2022 | Bradycardia | 4 | Patient |
| 2022 | Bacterial Infection | 3 | Patient |
| 2022 | Atrial Fibrillation | 1 | Patient |
| 2022 | Asystole | 1 | Patient |
| 2022 | Arrhythmia | 3 | Patient |
| 2022 | Unstable Capture Threshold | 11 | Device |
| 2022 | Under-Sensing | 70 | Device |
| 2022 | Stretched | 2 | Device |
| 2022 | Signal Artifact/Noise | 92 | Device |
| 2022 | Positioning Problem | 17 | Device |
| 2022 | Positioning Failure | 14 | Device |
| 2022 | Pacing Problem | 13 | Device |
| 2022 | Over-Sensing | 303 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Material Twisted/Bent | 4 | Device |
| 2022 | Material Integrity Problem | 4 | Device |
| 2022 | Low impedance | 46 | Device |
| 2022 | Intermittent Capture | 4 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 38 | Device |
| 2022 | Impedance Problem | 100 | Device |
| 2022 | High impedance | 153 | Device |
| 2022 | High Capture Threshold | 83 | Device |
| 2022 | Fracture | 85 | Device |
| 2022 | Failure to Capture | 28 | Device |
| 2022 | Electrical /Electronic Property Problem | 3 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Device-Device Incompatibility | 1 | Device |
| 2022 | Device Sensing Problem | 10 | Device |
| 2022 | Device Dislodged or Dislocated | 37 | Device |
| 2022 | Device Contamination with Body Fluid | 1 | Device |
| 2022 | Defibrillation/Stimulation Problem | 3 | Device |
| 2022 | Decreased Sensitivity | 67 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Capturing Problem | 37 | Device |
| 2022 | Break | 12 | Device |
| 2022 | Appropriate Term/Code Not Available | 12 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 111 | Device |
| 2022 | Activation, Positioning or Separation Problem | 13 | Device |
| 2021 | Unspecified Infection | 3 | Patient |
| 2021 | Twiddlers Syndrome | 1 | Patient |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2021 | Bacteremia | 1 | Patient |
| 2021 | Under-Sensing | 2 | Device |
| 2021 | Signal Artifact/Noise | 4 | Device |
| 2021 | Pacing Problem | 2 | Device |
| 2021 | Over-Sensing | 23 | Device |
| 2021 | Material Deformation | 1 | Device |
| 2021 | Low impedance | 7 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2021 | Impedance Problem | 11 | Device |
| 2021 | High impedance | 12 | Device |
| 2021 | High Capture Threshold | 9 | Device |
| 2021 | Fracture | 4 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Decreased Sensitivity | 5 | Device |
| 2021 | Capturing Problem | 2 | Device |
| 2021 | Break | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2020 | Under-Sensing | 1 | Device |
| 2020 | Signal Artifact/Noise | 3 | Device |
| 2020 | Over-Sensing | 11 | Device |
| 2020 | Low impedance | 4 | Device |
| 2020 | Impedance Problem | 3 | Device |
| 2020 | High impedance | 4 | Device |
| 2020 | High Capture Threshold | 2 | Device |
| 2020 | Fracture | 2 | Device |
| 2020 | Device Sensing Problem | 1 | Device |
| 2020 | Device Dislodged or Dislocated | 1 | Device |
| 2020 | Decreased Sensitivity | 2 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |