SYSTEM, HEMODYNAMIC, IMPLANTABLE
This device is manufactured by ST JUDE MEDICAL, ST JUDE MEDICAL (AF-ST PAUL).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hypovolemia | 1 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Wireless Communication Problem | 1 | Device |
| 2024 | Unintended Electrical Shock | 1 | Device |
| 2024 | Sparking | 16 | Device |
| 2024 | Smoking | 1 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | Melted | 3 | Device |
| 2024 | Material Frayed | 102 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Intermittent Loss of Power | 5 | Device |
| 2024 | Failure to Shut Off | 1 | Device |
| 2024 | Failure to Read Input Signal | 2 | Device |
| 2024 | Failure to Power Up | 17 | Device |
| 2024 | Electromagnetic Interference | 1 | Device |
| 2024 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Renal Impairment | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Wireless Communication Problem | 7 | Device |
| 2023 | Unexpected Shutdown | 1 | Device |
| 2023 | Thermal Decomposition of Device | 1 | Device |
| 2023 | Sparking | 21 | Device |
| 2023 | Power Problem | 1 | Device |
| 2023 | No Tactile Prompts/Feedback | 1 | Device |
| 2023 | Melted | 1 | Device |
| 2023 | Material Frayed | 159 | Device |
| 2023 | Loose or Intermittent Connection | 9 | Device |
| 2023 | Intermittent Loss of Power | 7 | Device |
| 2023 | Incorrect Measurement | 3 | Device |
| 2023 | Fire | 1 | Device |
| 2023 | Failure to Shut Off | 1 | Device |
| 2023 | Failure to Read Input Signal | 3 | Device |
| 2023 | Failure to Power Up | 26 | Device |
| 2023 | Electromagnetic Interference | 3 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Device Emits Odor | 1 | Device |
| 2023 | Communication or Transmission Problem | 2 | Device |
| 2023 | Break | 5 | Device |
| 2023 | Application Program Freezes, Becomes Nonfunctional | 9 | Device |
| 2022 | Wireless Communication Problem | 2 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | Sparking | 2 | Device |
| 2022 | No Tactile Prompts/Feedback | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Separation | 1 | Device |
| 2022 | Material Frayed | 72 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Intermittent Loss of Power | 4 | Device |
| 2022 | Failure to Read Input Signal | 4 | Device |
| 2022 | Failure to Power Up | 4 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Application Program Freezes, Becomes Nonfunctional | 1 | Device |
| 2021 | Material Frayed | 43 | Device |
| 2020 | Material Frayed | 31 | Device |