DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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 | Vomiting | 1 | Patient |
| 2024 | Unspecified Infection | 17 | Patient |
| 2024 | Tachycardia | 8 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Shock from Patient Lead(s) | 21 | Patient |
| 2024 | Septic Shock | 1 | Patient |
| 2024 | Sepsis | 3 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Pain | 2 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Fever | 2 | Patient |
| 2024 | Erythema | 2 | Patient |
| 2024 | Erosion | 2 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Dyspnea | 2 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2024 | Dizziness | 2 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Chest Pain | 2 | Patient |
| 2024 | Bradycardia | 6 | Patient |
| 2024 | Bacterial Infection | 3 | Patient |
| 2024 | Bacteremia | 3 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Unable to Obtain Readings | 1 | Device |
| 2024 | Premature Discharge of Battery | 12 | Device |
| 2024 | Pacing Problem | 16 | Device |
| 2024 | Over-Sensing | 3 | Device |
| 2024 | Migration or Expulsion of Device | 1 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 15 | Device |
| 2024 | Failure to Interrogate | 1 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 5 | Device |
| 2024 | Failure to Charge | 1 | Device |
| 2024 | Electromagnetic Interference | 3 | Device |
| 2024 | Electrical /Electronic Property Problem | 10 | Device |
| 2024 | Device-Device Incompatibility | 1 | Device |
| 2024 | Device Sensing Problem | 15 | Device |
| 2024 | Delayed Charge Time | 1 | Device |
| 2024 | Defibrillation/Stimulation Problem | 1 | Device |
| 2024 | Data Problem | 1 | Device |
| 2024 | Communication or Transmission Problem | 3 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 8 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 17 | Device |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Unspecified Infection | 26 | Patient |
| 2023 | Tinnitus | 1 | Patient |
| 2023 | Tachycardia | 3 | Patient |
| 2023 | Syncope/Fainting | 5 | Patient |
| 2023 | Shock from Patient Lead(s) | 15 | Patient |
| 2023 | Sepsis | 5 | Patient |
| 2023 | Purulent Discharge | 3 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Malaise | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2023 | Irregular Pulse | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Hematoma | 3 | Patient |
| 2023 | Head Injury | 1 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fever | 2 | Patient |
| 2023 | Fall | 4 | Patient |
| 2023 | Erythema | 3 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Chest Pain | 3 | Patient |
| 2023 | Bradycardia | 8 | Patient |
| 2023 | Bacterial Infection | 2 | Patient |
| 2023 | Bacteremia | 2 | Patient |
| 2023 | Atrial Fibrillation | 2 | Patient |
| 2023 | Arrhythmia | 2 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Signal Artifact/Noise | 4 | Device |
| 2023 | Protective Measures Problem | 1 | Device |
| 2023 | Premature Discharge of Battery | 13 | Device |
| 2023 | Pacing Problem | 13 | Device |
| 2023 | Over-Sensing | 6 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Missing Test Results | 1 | Device |
| 2023 | Migration or Expulsion of Device | 3 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 15 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2023 | Electromagnetic Interference | 10 | Device |
| 2023 | Electrical /Electronic Property Problem | 8 | Device |
| 2023 | Difficult to Insert | 1 | Device |
| 2023 | Device Sensing Problem | 16 | Device |
| 2023 | Device Alarm System | 1 | Device |
| 2023 | Communication or Transmission Problem | 3 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 13 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2022 | Unspecified Infection | 3 | Patient |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Shock from Patient Lead(s) | 2 | Patient |
| 2022 | Presyncope | 1 | Patient |
| 2022 | Low Cardiac Output | 1 | Patient |
| 2022 | Ischemic Heart Disease | 1 | Patient |
| 2022 | Cardiomyopathy | 1 | Patient |
| 2022 | Arrhythmia | 1 | Patient |
| 2022 | Unable to Obtain Readings | 3 | Device |
| 2022 | Signal Artifact/Noise | 4 | Device |
| 2022 | Premature Discharge of Battery | 16 | Device |
| 2022 | Pacing Problem | 10 | Device |
| 2022 | Over-Sensing | 4 | Device |
| 2022 | Misconnection | 1 | Device |
| 2022 | Migration or Expulsion of Device | 1 | Device |
| 2022 | Mechanical Problem | 5 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Incorrect Measurement | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | Failure to Interrogate | 2 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 9 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Electromagnetic Interference | 4 | Device |
| 2022 | Electrical /Electronic Property Problem | 4 | Device |
| 2022 | Device Sensing Problem | 16 | Device |
| 2022 | Defibrillation/Stimulation Problem | 2 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 5 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Cardiac Arrest | 1 | Patient |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Protective Measures Problem | 1 | Device |
| 2021 | Premature Discharge of Battery | 1 | Device |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2021 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2021 | Electromagnetic Interference | 2 | Device |
| 2021 | Device Sensing Problem | 2 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Paresthesia | 1 | Patient |
| 2020 | Chest Pain | 1 | Patient |
| 2020 | Signal Artifact/Noise | 1 | Device |
| 2020 | Premature Discharge of Battery | 1 | Device |
| 2020 | Over-Sensing | 1 | Device |
| 2020 | Device Sensing Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2019 | Under-Sensing | 1 | Device |
| 2019 | Unauthorized Access to Computer System | 1 | Device |
| 2019 | Signal Artifact/Noise | 8 | Device |
| 2019 | Premature Discharge of Battery | 15 | Device |
| 2019 | Pacing Problem | 10 | Device |
| 2019 | Over-Sensing | 8 | Device |
| 2019 | Output above Specifications | 1 | Device |
| 2019 | Output Problem | 1 | Device |
| 2019 | Misconnection | 3 | Device |
| 2019 | Migration or Expulsion of Device | 5 | Device |
| 2019 | Mechanical Problem | 17 | Device |
| 2019 | Loose or Intermittent Connection | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Incorrect Measurement | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 18 | Device |
| 2019 | High impedance | 7 | Device |
| 2019 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2019 | Electromagnetic Interference | 8 | Device |
| 2019 | Electrical /Electronic Property Problem | 33 | Device |
| 2019 | Device-Device Incompatibility | 1 | Device |
| 2019 | Device Sensing Problem | 27 | Device |
| 2019 | Device Damaged by Another Device | 1 | Device |
| 2019 | Device Alarm System | 1 | Device |
| 2019 | Defibrillation/Stimulation Problem | 2 | Device |
| 2019 | Defective Device | 1 | Device |
| 2019 | Data Problem | 1 | Device |
| 2019 | Component Missing | 1 | Device |
| 2019 | Capturing Problem | 1 | Device |
| 2019 | Battery Problem | 3 | Device |
| 2019 | Appropriate Term/Code Not Available | 9 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 120 | Device |
| 2018 | Unintended Movement | 1 | Device |
| 2018 | Under-Sensing | 3 | Device |
| 2018 | Unable to Obtain Readings | 2 | Device |
| 2018 | Signal Artifact/Noise | 1 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Premature Discharge of Battery | 9 | Device |
| 2018 | Pacing Problem | 6 | Device |
| 2018 | Over-Sensing | 10 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Nonstandard Device | 11 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | Misconnection | 2 | Device |
| 2018 | Migration or Expulsion of Device | 5 | Device |
| 2018 | Microbial Contamination of Device | 1 | Device |
| 2018 | Mechanical Problem | 27 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Low impedance | 1 | Device |
| 2018 | Invalid Sensing | 7 | Device |
| 2018 | Insufficient Information | 4 | Device |
| 2018 | Incorrect Measurement | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 20 | Device |
| 2018 | Impedance Problem | 1 | Device |
| 2018 | High impedance | 8 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Failure to Interrogate | 1 | Device |
| 2018 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2018 | Failure to Charge | 1 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Electromagnetic Interference | 4 | Device |
| 2018 | Electrical /Electronic Property Problem | 24 | Device |
| 2018 | Display or Visual Feedback Problem | 1 | Device |
| 2018 | Device Sensing Problem | 14 | Device |
| 2018 | Device Operates Differently Than Expected | 4 | Device |
| 2018 | Delayed Charge Time | 1 | Device |
| 2018 | Defibrillation/Stimulation Problem | 3 | Device |
| 2018 | Data Problem | 2 | Device |
| 2018 | Connection Problem | 1 | Device |
| 2018 | Communication or Transmission Problem | 3 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Battery Problem | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 8 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 115 | Device |
| 2017 | Unstable Capture Threshold | 1 | Device |
| 2017 | Under-Sensing | 1 | Device |
| 2017 | Unable to Obtain Readings | 2 | Device |
| 2017 | Signal Artifact/Noise | 1 | Device |
| 2017 | Protective Measures Problem | 1 | Device |
| 2017 | Pacing Problem | 4 | Device |
| 2017 | Over-Sensing | 6 | Device |
| 2017 | Misconnection | 5 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Mechanical Problem | 16 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Invalid Sensing | 9 | Device |
| 2017 | Intermittent Shock/Stimulation | 1 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 8 | Device |
| 2017 | Impedance Problem | 3 | Device |
| 2017 | High impedance | 5 | Device |
| 2017 | High Capture Threshold | 2 | Device |
| 2017 | Failure to Capture | 1 | Device |
| 2017 | Electrical /Electronic Property Problem | 6 | Device |
| 2017 | Device Sensing Problem | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Device Contamination with Body Fluid | 1 | Device |
| 2017 | Decreased Sensitivity | 1 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Communication or Transmission Problem | 1 | Device |
| 2017 | Capturing Problem | 1 | Device |
| 2017 | Battery Problem | 3 | Device |
| 2017 | Appropriate Term/Code Not Available | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2016 | Pacing Problem | 2 | Device |
| 2016 | Misconnection | 1 | Device |
| 2016 | Mechanical Problem | 3 | Device |
| 2016 | Incorrect Measurement | 1 | Device |
| 2016 | Failure to Interrogate | 1 | Device |
| 2016 | Device Sensing Problem | 1 | Device |