IMPLANTABLE TACHY LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC NEUROMODULATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 1 | Patient |
| 2024 | Unspecified Infection | 12 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Tachycardia | 2 | Patient |
| 2024 | Syncope/Fainting | 2 | Patient |
| 2024 | Shock from Patient Lead(s) | 10 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Obstruction/Occlusion | 1 | Patient |
| 2024 | Malaise | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Insufficient Information | 5 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Failure of Implant | 4 | Patient |
| 2024 | Erythema | 3 | Patient |
| 2024 | Endocarditis | 2 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Ectopic Heartbeat | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Chest Pain | 5 | Patient |
| 2024 | Cellulitis | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Bacteremia | 1 | Patient |
| 2024 | Asystole | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Unstable Capture Threshold | 1 | Device |
| 2024 | Under-Sensing | 19 | Device |
| 2024 | Signal Artifact/Noise | 24 | Device |
| 2024 | Pacing Problem | 5 | Device |
| 2024 | Over-Sensing | 45 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Low impedance | 4 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2024 | Impedance Problem | 31 | Device |
| 2024 | High impedance | 48 | Device |
| 2024 | High Capture Threshold | 17 | Device |
| 2024 | Fracture | 24 | Device |
| 2024 | Electrical /Electronic Property Problem | 2 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Defibrillation/Stimulation Problem | 1 | Device |
| 2024 | Decreased Sensitivity | 3 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Capturing Problem | 4 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Vascular Dissection | 1 | Patient |
| 2023 | Unspecified Infection | 19 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 4 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 9 | Patient |
| 2023 | Respiratory Arrest | 1 | Patient |
| 2023 | Purulent Discharge | 1 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Pocket Erosion | 4 | Patient |
| 2023 | Obstruction/Occlusion | 2 | Patient |
| 2023 | Non specific EKG/ECG Changes | 2 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2023 | Fungal Infection | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Failure of Implant | 3 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Dehydration | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Arrest | 2 | Patient |
| 2023 | Breast Cancer | 1 | Patient |
| 2023 | Bacterial Infection | 2 | Patient |
| 2023 | Bacteremia | 1 | Patient |
| 2023 | Asystole | 2 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Unstable Capture Threshold | 3 | Device |
| 2023 | Under-Sensing | 24 | Device |
| 2023 | Signal Artifact/Noise | 36 | Device |
| 2023 | Product Quality Problem | 1 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Pacing Problem | 4 | Device |
| 2023 | Over-Sensing | 59 | Device |
| 2023 | Mechanical Problem | 4 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Low impedance | 16 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Intermittent Capture | 3 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2023 | Impedance Problem | 37 | Device |
| 2023 | High impedance | 78 | Device |
| 2023 | High Sensing Threshold | 1 | Device |
| 2023 | High Capture Threshold | 29 | Device |
| 2023 | Fracture | 45 | Device |
| 2023 | Failure to Capture | 5 | Device |
| 2023 | Device Sensing Problem | 2 | Device |
| 2023 | Defibrillation/Stimulation Problem | 4 | Device |
| 2023 | Decreased Sensitivity | 14 | Device |
| 2023 | Capturing Problem | 8 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 7 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2022 | Unspecified Infection | 4 | Patient |
| 2022 | Syncope/Fainting | 2 | Patient |
| 2022 | Shock from Patient Lead(s) | 3 | Patient |
| 2022 | Sepsis | 3 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Failure of Implant | 8 | Patient |
| 2022 | Erosion | 1 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Bacteremia | 1 | Patient |
| 2022 | Atrial Fibrillation | 1 | Patient |
| 2022 | Unstable Capture Threshold | 2 | Device |
| 2022 | Under-Sensing | 12 | Device |
| 2022 | Signal Artifact/Noise | 40 | Device |
| 2022 | Pacing Problem | 3 | Device |
| 2022 | Over-Sensing | 69 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Low impedance | 13 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 14 | Device |
| 2022 | Impedance Problem | 54 | Device |
| 2022 | High impedance | 90 | Device |
| 2022 | High Capture Threshold | 29 | Device |
| 2022 | Fracture | 43 | Device |
| 2022 | Failure to Capture | 7 | Device |
| 2022 | Energy Output Problem | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Device Sensing Problem | 2 | Device |
| 2022 | Defective Component | 10 | Device |
| 2022 | Decreased Sensitivity | 15 | Device |
| 2022 | Connection Problem | 2 | Device |
| 2022 | Capturing Problem | 11 | Device |
| 2022 | Break | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 6 | Device |
| 2022 | Ambient Noise Problem | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2021 | Unspecified Infection | 5 | Patient |
| 2021 | Syncope/Fainting | 2 | Patient |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Sepsis | 2 | Patient |
| 2021 | Presyncope | 1 | Patient |
| 2021 | Pocket Erosion | 1 | Patient |
| 2021 | Insufficient Information | 50 | Patient |
| 2021 | Dizziness | 1 | Patient |
| 2021 | Unstable Capture Threshold | 3 | Device |
| 2021 | Under-Sensing | 1 | Device |
| 2021 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2021 | Signal Artifact/Noise | 14 | Device |
| 2021 | Patient Device Interaction Problem | 1 | Device |
| 2021 | Pacing Problem | 3 | Device |
| 2021 | Over-Sensing | 16 | Device |
| 2021 | Noise, Audible | 2 | Device |
| 2021 | No Pacing | 1 | Device |
| 2021 | Mechanical Problem | 1 | Device |
| 2021 | Low impedance | 3 | Device |
| 2021 | Insufficient Information | 12 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2021 | Impedance Problem | 23 | Device |
| 2021 | High impedance | 28 | Device |
| 2021 | High Capture Threshold | 6 | Device |
| 2021 | Fracture | 4 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Device Sensing Problem | 1 | Device |
| 2021 | Device Displays Incorrect Message | 2 | Device |
| 2021 | Decreased Sensitivity | 1 | Device |
| 2021 | Capturing Problem | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Ventricular Fibrillation | 1 | Patient |
| 2020 | Unspecified Infection | 3 | Patient |
| 2020 | Tachycardia | 1 | Patient |
| 2020 | Shock from Patient Lead(s) | 2 | Patient |
| 2020 | Sepsis | 1 | Patient |
| 2020 | Insufficient Information | 19 | Patient |
| 2020 | Erosion | 1 | Patient |
| 2020 | Bruise/Contusion | 1 | Patient |
| 2020 | Under-Sensing | 4 | Device |
| 2020 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2020 | Signal Artifact/Noise | 2 | Device |
| 2020 | Sensing Intermittently | 1 | Device |
| 2020 | Product Quality Problem | 2 | Device |
| 2020 | Pacing Problem | 3 | Device |
| 2020 | Over-Sensing | 10 | Device |
| 2020 | Noise, Audible | 3 | Device |
| 2020 | Low impedance | 1 | Device |
| 2020 | Intermittent Capture | 1 | Device |
| 2020 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2020 | Impedance Problem | 10 | Device |
| 2020 | High impedance | 12 | Device |
| 2020 | High Capture Threshold | 3 | Device |
| 2020 | Fracture | 4 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Decreased Sensitivity | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 3 | Device |