PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
This device is manufactured by MEDTRONIC NEUROMODULATION, MEDTRONIC NEUROMODULATION SULLIVAN LAKE, RICE CREEK MANUFACTURING.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Skin Erosion | 1 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Malaise | 1 | Patient |
| 2024 | Insufficient Information | 4 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 3 | Patient |
| 2024 | Ambulation Difficulties | 1 | Patient |
| 2024 | Pumping Stopped | 3 | Device |
| 2024 | Obstruction of Flow | 2 | Device |
| 2024 | Migration or Expulsion of Device | 2 | Device |
| 2024 | Material Integrity Problem | 3 | Device |
| 2024 | Insufficient Information | 6 | Device |
| 2024 | Insufficient Flow or Under Infusion | 2 | Device |
| 2024 | Infusion or Flow Problem | 2 | Device |
| 2024 | Human-Device Interface Problem | 1 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Excess Flow or Over-Infusion | 1 | Device |
| 2024 | Device Alarm System | 1 | Device |
| 2024 | Application Program Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Weight Changes | 1 | Patient |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Purulent Discharge | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Muscular Rigidity | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Emotional Changes | 1 | Patient |
| 2023 | Cognitive Changes | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 5 | Patient |
| 2023 | Aneurysm | 1 | Patient |
| 2023 | Pumping Stopped | 2 | Device |
| 2023 | No Audible Alarm | 1 | Device |
| 2023 | Migration or Expulsion of Device | 4 | Device |
| 2023 | Material Integrity Problem | 2 | Device |
| 2023 | Insufficient Information | 2 | Device |
| 2023 | Insufficient Flow or Under Infusion | 3 | Device |
| 2023 | Infusion or Flow Problem | 2 | Device |
| 2023 | Inappropriate or Unexpected Reset | 1 | Device |
| 2023 | Improper Flow or Infusion | 3 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2023 | Filling Problem | 3 | Device |
| 2023 | Excess Flow or Over-Infusion | 1 | Device |
| 2023 | Electromagnetic Interference | 2 | Device |
| 2023 | Disconnection | 2 | Device |
| 2023 | Difficult to Advance | 1 | Device |
| 2023 | Data Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Twiddlers Syndrome | 1 | Patient |
| 2022 | Post Operative Wound Infection | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Obstruction of Flow | 2 | Device |
| 2022 | Migration or Expulsion of Device | 2 | Device |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Insufficient Flow or Under Infusion | 1 | Device |
| 2022 | Infusion or Flow Problem | 3 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2022 | Filling Problem | 2 | Device |
| 2022 | Excess Flow or Over-Infusion | 1 | Device |
| 2022 | Electromagnetic Interference | 2 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2021 | Foreign Body Reaction | 1 | Patient |
| 2021 | Cyst(s) | 1 | Patient |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Muscular Rigidity | 1 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Positioning Problem | 1 | Device |
| 2020 | Obstruction of Flow | 1 | Device |
| 2020 | Nonstandard Device | 1 | Device |
| 2020 | Migration or Expulsion of Device | 1 | Device |
| 2020 | Material Integrity Problem | 1 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Insufficient Flow or Under Infusion | 1 | Device |
| 2020 | Electromagnetic Interference | 1 | Device |