FORTIFY ASSURA DR ICD, US

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

This device is manufactured by ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL - NEUROMODULATION (PUERTO RICO ), ST JUDE MEDICAL / ABBOTT MEDICAL.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unspecified Infection 9 Patient
2024 Syncope/Fainting 1 Patient
2024 Pocket Erosion 4 Patient
2024 Pericardial Effusion 1 Patient
2024 Insufficient Information 4 Patient
2024 Hemorrhage/Blood Loss/Bleeding 1 Patient
2024 Hematoma 1 Patient
2024 Discomfort 6 Patient
2024 Arrhythmia 8 Patient
2024 Use of Device Problem 1 Device
2024 Under-Sensing 4 Device
2024 Premature Discharge of Battery 6 Device
2024 Pacing Problem 5 Device
2024 Pacing Asynchronously 2 Device
2024 Over-Sensing 28 Device
2024 No Pacing 1 Device
2024 No Apparent Adverse Event 1 Device
2024 Migration or Expulsion of Device 1 Device
2024 Low impedance 2 Device
2024 Loose or Intermittent Connection 1 Device
2024 Interrogation Problem 1 Device
2024 Incorrect, Inadequate or Imprecise Result or Readings 1 Device
2024 Incorrect Measurement 2 Device
2024 Incorrect Interpretation of Signal 2 Device
2024 Inappropriate/Inadequate Shock/Stimulation 8 Device
2024 Inappropriate or Unexpected Reset 5 Device
2024 Failure to Interrogate 5 Device
2024 Failure to Deliver Shock/Stimulation 2 Device
2024 Failure to Convert Rhythm 2 Device
2024 Failure to Charge 1 Device
2024 Failure to Capture 1 Device
2024 Environmental Compatibility Problem 1 Device
2024 Data Problem 1 Device
2024 Capturing Problem 1 Device
2024 Adverse Event Without Identified Device or Use Problem 7 Device
2023 Unspecified Infection 11 Patient
2023 Pocket Erosion 5 Patient
2023 Insufficient Information 8 Patient
2023 Dyspnea 1 Patient
2023 Dizziness 1 Patient
2023 Discomfort 4 Patient
2023 Arrhythmia 7 Patient
2023 Under-Sensing 7 Device
2023 Tactile Prompts/Feedback 1 Device
2023 Signal Artifact/Noise 3 Device
2023 Product Quality Problem 1 Device
2023 Premature Discharge of Battery 17 Device
2023 Pacing Problem 6 Device
2023 Pacing Asynchronously 3 Device
2023 Over-Sensing 64 Device
2023 No Pacing 1 Device
2023 No Apparent Adverse Event 2 Device
2023 Migration or Expulsion of Device 1 Device
2023 Loose or Intermittent Connection 1 Device
2023 Interrogation Problem 1 Device
2023 Intermittent Capture 2 Device
2023 Insufficient Information 1 Device
2023 Incorrect Measurement 2 Device
2023 Incorrect Interpretation of Signal 16 Device
2023 Inappropriate/Inadequate Shock/Stimulation 20 Device
2023 Inappropriate or Unexpected Reset 9 Device
2023 High impedance 3 Device
2023 Failure to Interrogate 4 Device
2023 Failure to Disconnect 1 Device
2023 Failure to Deliver Shock/Stimulation 2 Device
2023 Failure to Convert Rhythm 2 Device
2023 Failure to Capture 1 Device
2023 Environmental Compatibility Problem 1 Device
2023 Device Sensing Problem 1 Device
2023 Delayed Charge Time 2 Device
2023 Connection Problem 1 Device
2023 Capturing Problem 2 Device
2023 Adverse Event Without Identified Device or Use Problem 13 Device
2022 Syncope/Fainting 1 Patient
2022 Pocket Erosion 1 Patient
2022 Insufficient Information 1 Patient
2022 Failure of Implant 1 Patient
2022 Arrhythmia 2 Patient
2022 Under-Sensing 9 Device
2022 Tactile Prompts/Feedback 1 Device
2022 Signal Artifact/Noise 2 Device
2022 Premature Discharge of Battery 27 Device
2022 Pacing Problem 6 Device
2022 Over-Sensing 48 Device
2022 No Apparent Adverse Event 2 Device
2022 Interrogation Problem 1 Device
2022 Intermittent Capture 1 Device
2022 Insufficient Information 3 Device
2022 Incorrect Measurement 1 Device
2022 Incorrect Interpretation of Signal 13 Device
2022 Inappropriate/Inadequate Shock/Stimulation 17 Device
2022 Inappropriate or Unexpected Reset 7 Device
2022 High impedance 3 Device
2022 Failure to Interrogate 8 Device
2022 Failure to Deliver Shock/Stimulation 2 Device
2022 Failure to Convert Rhythm 3 Device
2022 Failure to Capture 1 Device
2022 Environmental Compatibility Problem 1 Device
2022 Device Sensing Problem 2 Device
2022 Defective Device 3 Device
2022 Defective Component 1 Device
2022 Data Problem 2 Device
2022 Adverse Event Without Identified Device or Use Problem 9 Device
2021 Insufficient Information 1 Patient
2021 Premature Discharge of Battery 1 Device
2021 Insufficient Information 1 Device
2021 High impedance 1 Device
2021 Failure to Deliver Shock/Stimulation 1 Device
2021 Device Sensing Problem 1 Device
2021 Adverse Event Without Identified Device or Use Problem 1 Device
2020 Adverse Event Without Identified Device or Use Problem 1 Device