DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
This device is manufactured by STRYKER MEDICAL, nan.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Fatigue | 1 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Over-Sensing | 2 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2024 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 1 | Device |
| 2024 | Delayed Program or Algorithm Execution | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 2 | Patient |
| 2023 | Shock | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Electric Shock | 2 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Premature Discharge of Battery | 4 | Device |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Over-Sensing | 2 | Device |
| 2023 | Loss of Data | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Incorrect Interpretation of Signal | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 2 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Delayed Charge Time | 1 | Device |
| 2023 | Defective Component | 1 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Inflammation | 1 | Patient |
| 2022 | Premature Discharge of Battery | 2 | Device |
| 2022 | Incomplete or Inadequate Connection | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | Wireless Communication Problem | 1 | Device |
| 2019 | Unexpected Therapeutic Results | 2 | Device |
| 2019 | Scratched Material | 1 | Device |
| 2019 | Premature Discharge of Battery | 3 | Device |
| 2019 | Patient Data Problem | 2 | Device |
| 2019 | Pacing Intermittently | 1 | Device |
| 2019 | Over-Sensing | 26 | Device |
| 2019 | No Pacing | 4 | Device |
| 2019 | Missing Information | 1 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Low impedance | 2 | Device |
| 2019 | Interrogation Problem | 1 | Device |
| 2019 | Incorrect Measurement | 1 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 14 | Device |
| 2019 | Inappropriate or Unexpected Reset | 2 | Device |
| 2019 | High impedance | 8 | Device |
| 2019 | Failure to Sense | 3 | Device |
| 2019 | Failure to Interrogate | 2 | Device |
| 2019 | Failure to Deliver Shock/Stimulation | 1 | Device |
| 2019 | Failure to Capture | 1 | Device |
| 2019 | Electrical /Electronic Property Problem | 1 | Device |
| 2019 | Display or Visual Feedback Problem | 3 | Device |
| 2019 | Device Sensing Problem | 3 | Device |
| 2019 | Device Displays Incorrect Message | 4 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Delayed Charge Time | 2 | Device |
| 2019 | Data Problem | 9 | Device |
| 2019 | Connection Problem | 2 | Device |
| 2019 | Communication or Transmission Problem | 3 | Device |
| 2019 | Charging Problem | 1 | Device |
| 2019 | Battery Problem | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2018 | Wireless Communication Problem | 1 | Device |
| 2018 | Unintended Movement | 5 | Device |
| 2018 | Unexpected Therapeutic Results | 3 | Device |
| 2018 | Unable to Obtain Readings | 1 | Device |
| 2018 | Telemetry Discrepancy | 1 | Device |
| 2018 | Signal Artifact/Noise | 1 | Device |
| 2018 | Reset Problem | 1 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Premature Elective Replacement Indicator | 3 | Device |
| 2018 | Premature Discharge of Battery | 6 | Device |
| 2018 | Pacing Problem | 1 | Device |
| 2018 | Pacing Inadequately | 1 | Device |
| 2018 | Over-Sensing | 62 | Device |
| 2018 | Nonstandard Device | 11 | Device |
| 2018 | No Pacing | 2 | Device |
| 2018 | No Display/Image | 1 | Device |
| 2018 | No Device Output | 1 | Device |
| 2018 | No Apparent Adverse Event | 26 | Device |
| 2018 | Migration or Expulsion of Device | 2 | Device |
| 2018 | Mechanical Jam | 1 | Device |
| 2018 | Low impedance | 3 | Device |
| 2018 | Intermittent Continuity | 1 | Device |
| 2018 | Intermittent Capture | 1 | Device |
| 2018 | Insufficient Information | 3 | Device |
| 2018 | Incorrect Measurement | 3 | Device |
| 2018 | Incomplete or Inadequate Connection | 1 | Device |
| 2018 | Inappropriate/Inadequate Shock/Stimulation | 17 | Device |
| 2018 | Inappropriate or Unexpected Reset | 3 | Device |
| 2018 | Impedance Problem | 4 | Device |
| 2018 | High impedance | 10 | Device |
| 2018 | High Capture Threshold | 4 | Device |
| 2018 | Failure to Transmit Record | 1 | Device |
| 2018 | Failure to Interrogate | 5 | Device |
| 2018 | Failure to Capture | 1 | Device |
| 2018 | Display or Visual Feedback Problem | 4 | Device |
| 2018 | Device Sensing Problem | 3 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Device Displays Incorrect Message | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 1 | Device |
| 2018 | Delayed Charge Time | 1 | Device |
| 2018 | Defibrillation/Stimulation Problem | 1 | Device |
| 2018 | Data Problem | 2 | Device |
| 2018 | Connection Problem | 7 | Device |
| 2018 | Communication or Transmission Problem | 6 | Device |
| 2018 | Battery Problem | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 12 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 90 | Device |
| 2017 | Bradycardia | 1 | Patient |
| 2017 | Wireless Communication Problem | 9 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Unexpected Therapeutic Results | 1 | Device |
| 2017 | Telemetry Discrepancy | 2 | Device |
| 2017 | Reset Problem | 2 | Device |
| 2017 | Premature Discharge of Battery | 13 | Device |
| 2017 | Pacing Inadequately | 1 | Device |
| 2017 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2017 | Over-Sensing | 45 | Device |
| 2017 | No Pacing | 4 | Device |
| 2017 | No Display/Image | 1 | Device |
| 2017 | Manufacturing, Packaging or Shipping Problem | 3 | Device |
| 2017 | Low impedance | 2 | Device |
| 2017 | Low Battery | 1 | Device |
| 2017 | Loss of Threshold | 1 | Device |
| 2017 | Loss of Data | 1 | Device |
| 2017 | Issue With Displayed Error Message | 1 | Device |
| 2017 | Intermittent Capture | 1 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Inappropriate/Inadequate Shock/Stimulation | 12 | Device |
| 2017 | Inappropriate or Unexpected Reset | 4 | Device |
| 2017 | Impedance Problem | 3 | Device |
| 2017 | High impedance | 10 | Device |
| 2017 | Failure to Transmit Record | 1 | Device |
| 2017 | Failure to Select Signal | 1 | Device |
| 2017 | Failure to Interrogate | 29 | Device |
| 2017 | Failure to Capture | 3 | Device |
| 2017 | Electromagnetic Interference | 1 | Device |
| 2017 | Display or Visual Feedback Problem | 3 | Device |
| 2017 | Display Difficult to Read | 1 | Device |
| 2017 | Device Slipped | 1 | Device |
| 2017 | Device Sensing Problem | 3 | Device |
| 2017 | Device Packaging Compromised | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Device Displays Incorrect Message | 16 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Delayed Charge Time | 1 | Device |
| 2017 | Defibrillation/Stimulation Problem | 3 | Device |
| 2017 | Data Problem | 1 | Device |
| 2017 | Contamination /Decontamination Problem | 2 | Device |
| 2017 | Connection Problem | 5 | Device |
| 2017 | Component Missing | 1 | Device |
| 2017 | Communication or Transmission Problem | 26 | Device |
| 2017 | Battery Problem | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2016 | Wireless Communication Problem | 1 | Device |
| 2016 | Unexpected Therapeutic Results | 2 | Device |
| 2016 | Telemetry Discrepancy | 2 | Device |
| 2016 | Reset Problem | 2 | Device |
| 2016 | Premature Discharge of Battery | 8 | Device |
| 2016 | Pacing Problem | 1 | Device |
| 2016 | Over-Sensing | 7 | Device |
| 2016 | No Pacing | 2 | Device |
| 2016 | Missing Test Results | 1 | Device |
| 2016 | Loss of Data | 1 | Device |
| 2016 | Issue With Displayed Error Message | 1 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2016 | Inappropriate or Unexpected Reset | 4 | Device |
| 2016 | Impedance Problem | 1 | Device |
| 2016 | High impedance | 1 | Device |
| 2016 | Fitting Problem | 2 | Device |
| 2016 | Failure to Transmit Record | 1 | Device |
| 2016 | Failure to Interrogate | 16 | Device |
| 2016 | Display or Visual Feedback Problem | 6 | Device |
| 2016 | Difficult to Interrogate | 3 | Device |
| 2016 | Device Operates Differently Than Expected | 7 | Device |
| 2016 | Device Displays Incorrect Message | 9 | Device |
| 2016 | Data Problem | 2 | Device |
| 2016 | Contamination /Decontamination Problem | 2 | Device |
| 2016 | Communication or Transmission Problem | 15 | Device |
| 2016 | Battery Problem | 1 | Device |
| 2016 | Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 8 | Device |