NEUROLOGICAL STEREOTAXIC INSTRUMENT
This device is manufactured by MEDTONIC, MEDTRONIC, MEDTRONIC NAVIGAITON, MEDTRONIC NAVIGATION, MEDTRONIC NAVIGATION (LITTLETON) and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Tissue Injury | 2 | Patient |
| 2024 | Unspecified Nervous System Problem | 1 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Brain Injury | 1 | Patient |
| 2024 | Awareness during Anaesthesia | 1 | Patient |
| 2024 | Ambulation Difficulties | 1 | Patient |
| 2024 | Use of Device Problem | 6 | Device |
| 2024 | Unintended Application Program Shut Down | 15 | Device |
| 2024 | Unexpected Shutdown | 37 | Device |
| 2024 | Power Problem | 3 | Device |
| 2024 | Naturally Worn | 1 | Device |
| 2024 | Mechanical Problem | 49 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 59 | Device |
| 2024 | Failure to Shut Off | 3 | Device |
| 2024 | Failure to Read Input Signal | 3 | Device |
| 2024 | Failure to Power Up | 4 | Device |
| 2024 | Excessive Heating | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 5 | Device |
| 2024 | Display or Visual Feedback Problem | 32 | Device |
| 2024 | Device Sensing Problem | 31 | Device |
| 2024 | Delayed Program or Algorithm Execution | 2 | Device |
| 2024 | Connection Problem | 4 | Device |
| 2024 | Computer Software Problem | 3 | Device |
| 2024 | Communication or Transmission Problem | 12 | Device |
| 2024 | Application Program Problem | 115 | Device |
| 2024 | Application Program Freezes, Becomes Nonfunctional | 36 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2024 | Activation, Positioning or Separation Problem | 2 | Device |
| 2023 | Unspecified Tissue Injury | 5 | Patient |
| 2023 | Unintended Radiation Exposure | 1 | Patient |
| 2023 | Transient Ischemic Attack | 1 | Patient |
| 2023 | Loss of Range of Motion | 2 | Patient |
| 2023 | Ischemia | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Cerebrospinal Fluid Leakage | 3 | Patient |
| 2023 | Cardiovascular Insufficiency | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Use of Device Problem | 13 | Device |
| 2023 | Unintended Application Program Shut Down | 1 | Device |
| 2023 | Unexpected Shutdown | 12 | Device |
| 2023 | Temperature Problem | 1 | Device |
| 2023 | Power Problem | 7 | Device |
| 2023 | Output Problem | 3 | Device |
| 2023 | No Device Output | 4 | Device |
| 2023 | Mechanics Altered | 2 | Device |
| 2023 | Mechanical Problem | 27 | Device |
| 2023 | Material Integrity Problem | 34 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 34 | Device |
| 2023 | Imprecision | 61 | Device |
| 2023 | Human-Device Interface Problem | 25 | Device |
| 2023 | Failure to Shut Off | 2 | Device |
| 2023 | Failure to Read Input Signal | 1 | Device |
| 2023 | Failure to Power Up | 2 | Device |
| 2023 | Excessive Heating | 1 | Device |
| 2023 | Environmental Compatibility Problem | 34 | Device |
| 2023 | Electrical /Electronic Property Problem | 7 | Device |
| 2023 | Display or Visual Feedback Problem | 25 | Device |
| 2023 | Device Sensing Problem | 52 | Device |
| 2023 | Delayed Program or Algorithm Execution | 2 | Device |
| 2023 | Degraded | 1 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Connection Problem | 14 | Device |
| 2023 | Computer Software Problem | 3 | Device |
| 2023 | Computer Operating System Problem | 6 | Device |
| 2023 | Complete Loss of Power | 1 | Device |
| 2023 | Communication or Transmission Problem | 16 | Device |
| 2023 | Audible Prompt/Feedback Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Application Program Problem | 55 | Device |
| 2023 | Application Program Freezes, Becomes Nonfunctional | 106 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 25 | Device |
| 2022 | Unspecified Tissue Injury | 2 | Patient |
| 2022 | Unspecified Nervous System Problem | 1 | Patient |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Sinus Perforation | 1 | Patient |
| 2022 | Paresis | 1 | Patient |
| 2022 | Nerve Damage | 1 | Patient |
| 2022 | Meningitis | 1 | Patient |
| 2022 | Intracranial Hemorrhage | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Coma | 1 | Patient |
| 2022 | Cerebrospinal Fluid Leakage | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unexpected Shutdown | 1 | Device |
| 2022 | Protective Measures Problem | 1 | Device |
| 2022 | Output Problem | 3 | Device |
| 2022 | Mechanics Altered | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Integrity Problem | 27 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 3 | Device |
| 2022 | Imprecision | 55 | Device |
| 2022 | Human-Device Interface Problem | 17 | Device |
| 2022 | Environmental Compatibility Problem | 33 | Device |
| 2022 | Electrical /Electronic Property Problem | 3 | Device |
| 2022 | Display or Visual Feedback Problem | 8 | Device |
| 2022 | Device Sensing Problem | 21 | Device |
| 2022 | Connection Problem | 15 | Device |
| 2022 | Computer Software Problem | 10 | Device |
| 2022 | Computer Operating System Problem | 1 | Device |
| 2022 | Communication or Transmission Problem | 14 | Device |
| 2022 | Application Program Freezes, Becomes Nonfunctional | 73 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 19 | Device |
| 2020 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2020 | Display or Visual Feedback Problem | 1 | Device |