DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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 | Wound Dehiscence | 1 | Patient |
| 2024 | Ventricular Fibrillation | 4 | Patient |
| 2024 | Ventilator Dependent | 1 | Patient |
| 2024 | Unspecified Infection | 9 | Patient |
| 2024 | Tachycardia | 5 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Shock from Patient Lead(s) | 26 | Patient |
| 2024 | Shock | 1 | Patient |
| 2024 | Renal Failure | 1 | Patient |
| 2024 | Purulent Discharge | 2 | Patient |
| 2024 | Presyncope | 2 | Patient |
| 2024 | Pain | 2 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Fungal Infection | 1 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Erythema | 2 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Bradycardia | 4 | Patient |
| 2024 | Bacterial Infection | 2 | Patient |
| 2024 | Bacteremia | 4 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Under-Sensing | 1 | Device |
| 2024 | Signal Artifact/Noise | 2 | Device |
| 2024 | Premature Discharge of Battery | 3 | Device |
| 2024 | Pacing Problem | 15 | Device |
| 2024 | Over-Sensing | 4 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 20 | Device |
| 2024 | Failure to Interrogate | 1 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 7 | Device |
| 2024 | Electromagnetic Interference | 6 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device-Device Incompatibility | 1 | Device |
| 2024 | Device Sensing Problem | 27 | Device |
| 2024 | Defibrillation/Stimulation Problem | 1 | Device |
| 2024 | Battery Problem: Low Impedance | 1 | Device |
| 2024 | Battery Problem | 2 | Device |
| 2024 | Appropriate Term/Code Not Available | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Unspecified Infection | 10 | Patient |
| 2023 | Tachycardia | 4 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Stroke/CVA | 2 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 34 | Patient |
| 2023 | Sepsis | 2 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Head Injury | 1 | Patient |
| 2023 | Fungal Infection | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Endocarditis | 2 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 2 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Chest Pain | 2 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Cancer Cells Dissemination | 1 | Patient |
| 2023 | Cancer | 1 | Patient |
| 2023 | Burning Sensation | 1 | Patient |
| 2023 | Breast Cancer | 1 | Patient |
| 2023 | Bradycardia | 5 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Bacteremia | 3 | Patient |
| 2023 | Unable to Obtain Readings | 3 | Device |
| 2023 | Signal Artifact/Noise | 5 | Device |
| 2023 | Reset Problem | 1 | Device |
| 2023 | Protective Measures Problem | 2 | Device |
| 2023 | Premature Discharge of Battery | 5 | Device |
| 2023 | Pacing Problem | 13 | Device |
| 2023 | Over-Sensing | 9 | Device |
| 2023 | Misconnection | 1 | Device |
| 2023 | Migration or Expulsion of Device | 3 | Device |
| 2023 | Mechanical Problem | 4 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | Insufficient Information | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 34 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | Failure to Deliver Shock/Stimulation | 3 | Device |
| 2023 | Failure to Charge | 1 | Device |
| 2023 | Electromagnetic Interference | 6 | Device |
| 2023 | Electrical /Electronic Property Problem | 3 | Device |
| 2023 | Device-Device Incompatibility | 1 | Device |
| 2023 | Device Sensing Problem | 29 | Device |
| 2023 | Delayed Charge Time | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 1 | Device |
| 2023 | Communication or Transmission Problem | 3 | Device |
| 2023 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2022 | Shock from Patient Lead(s) | 3 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Myocardial Infarction | 1 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Cardiac Arrest | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Signal Artifact/Noise | 3 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Pacing Problem | 3 | Device |
| 2022 | Over-Sensing | 6 | Device |
| 2022 | Migration or Expulsion of Device | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 16 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | False Alarm | 1 | Device |
| 2022 | Failure to Deliver Shock/Stimulation | 2 | Device |
| 2022 | Electromagnetic Interference | 6 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Device Sensing Problem | 18 | Device |
| 2022 | Battery Problem | 2 | Device |
| 2022 | Appropriate Term/Code Not Available | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 16 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Syncope/Fainting | 1 | Patient |
| 2021 | Swelling/ Edema | 1 | Patient |
| 2021 | Shock from Patient Lead(s) | 1 | Patient |
| 2021 | Insufficient Information | 2 | Patient |
| 2021 | Impaired Healing | 1 | Patient |
| 2021 | Bradycardia | 1 | Patient |
| 2021 | Anxiety | 1 | Patient |
| 2021 | Pacing Problem | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Asystole | 1 | Patient |
| 2020 | Electromagnetic Interference | 1 | Device |
| 2019 | Under-Sensing | 2 | Device |
| 2019 | Unable to Obtain Readings | 3 | Device |
| 2019 | Signal Artifact/Noise | 10 | Device |
| 2019 | Reset Problem | 1 | Device |
| 2019 | Protective Measures Problem | 3 | Device |
| 2019 | Premature Discharge of Battery | 3 | Device |
| 2019 | Positioning Problem | 1 | Device |
| 2019 | Pacing Problem | 3 | Device |
| 2019 | Over-Sensing | 15 | Device |
| 2019 | Output Problem | 1 | Device |
| 2019 | Misconnection | 2 | Device |
| 2019 | Migration or Expulsion of Device | 1 | Device |
| 2019 | Mechanical Problem | 12 | Device |
| 2019 | Loose or Intermittent Connection | 1 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 39 | Device |
| 2019 | Impedance Problem | 3 | Device |
| 2019 | High impedance | 2 | Device |
| 2019 | Failure to Interrogate | 1 | Device |
| 2019 | Electromagnetic Interference | 12 | Device |
| 2019 | Electrical /Electronic Property Problem | 5 | Device |
| 2019 | Device Sensing Problem | 41 | Device |
| 2019 | Device Contamination with Body Fluid | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 4 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 73 | Device |
| 2018 | Unstable Capture Threshold | 1 | Device |
| 2018 | Under-Sensing | 1 | Device |
| 2018 | Unable to Obtain Readings | 3 | Device |
| 2018 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2018 | Signal Artifact/Noise | 5 | Device |
| 2018 | Reset Problem | 1 | Device |
| 2018 | Protective Measures Problem | 2 | Device |
| 2018 | Premature Discharge of Battery | 3 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Patient-Device Incompatibility | 1 | Device |
| 2018 | Pacing Problem | 2 | Device |
| 2018 | Over-Sensing | 16 | Device |
| 2018 | Nonstandard Device | 2 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | No Apparent Adverse Event | 1 | Device |
| 2018 | Misconnection | 3 | Device |
| 2018 | Migration or Expulsion of Device | 5 | Device |
| 2018 | Mechanical Problem | 20 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Invalid Sensing | 12 | Device |
| 2018 | Incorrect Measurement | 3 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 37 | Device |
| 2018 | Inappropriate or Unexpected Reset | 1 | Device |
| 2018 | Impedance Problem | 1 | Device |
| 2018 | High impedance | 4 | Device |
| 2018 | High Capture Threshold | 2 | Device |
| 2018 | Failure to Interrogate | 2 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Electromagnetic Interference | 5 | Device |
| 2018 | Electrical Power Problem | 1 | Device |
| 2018 | Electrical /Electronic Property Problem | 4 | Device |
| 2018 | Display or Visual Feedback Problem | 1 | Device |
| 2018 | Device Sensing Problem | 25 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 1 | Device |
| 2018 | Device Appears to Trigger Rejection | 1 | Device |
| 2018 | Device Alarm System | 1 | Device |
| 2018 | Defibrillation/Stimulation Problem | 3 | Device |
| 2018 | Defective Alarm | 1 | Device |
| 2018 | Communication or Transmission Problem | 5 | Device |
| 2018 | Capturing Problem | 1 | Device |
| 2018 | Battery Problem | 1 | Device |
| 2018 | Arcing | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 6 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 47 | Device |
| 2018 | Activation Problem | 1 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Unable to Obtain Readings | 1 | Device |
| 2017 | Protective Measures Problem | 5 | Device |
| 2017 | Premature Discharge of Battery | 3 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Pocket Stimulation | 1 | Device |
| 2017 | Pacing Problem | 2 | Device |
| 2017 | Over-Sensing | 15 | Device |
| 2017 | Output Problem | 1 | Device |
| 2017 | Misconnection | 2 | Device |
| 2017 | Migration or Expulsion of Device | 2 | Device |
| 2017 | Mechanical Problem | 17 | Device |
| 2017 | Low impedance | 2 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Invalid Sensing | 22 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 24 | Device |
| 2017 | Impedance Problem | 1 | Device |
| 2017 | High impedance | 3 | Device |
| 2017 | Failure to Interrogate | 1 | Device |
| 2017 | Failure to Capture | 1 | Device |
| 2017 | Electrical /Electronic Property Problem | 2 | Device |
| 2017 | Device Sensing Problem | 3 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Defibrillation/Stimulation Problem | 2 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Communication or Transmission Problem | 2 | Device |
| 2017 | Capturing Problem | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 5 | Device |
| 2017 | Application Program Problem | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2016 | Over-Sensing | 2 | Device |
| 2016 | Output Problem | 1 | Device |
| 2016 | Missing Test Results | 1 | Device |
| 2016 | Misconnection | 1 | Device |
| 2016 | Mechanical Problem | 2 | Device |
| 2016 | Invalid Sensing | 2 | Device |
| 2016 | Incorrect Measurement | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2016 | Battery Problem | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 7 | Device |