FDA Adverse Event
Malfunction
Summary report: N
SOPHYSA
MDR report key: 15358748
·
Received September 5, 2022
Report
- Report Number
- 3001587388-2022-22432
- Event Type
- Malfunction
- Date Received
- September 5, 2022
- Date of Event
- June 20, 2022
- Report Date
- September 5, 2022
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- PMA / PMN Number
- K013488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT UNDERWENT AN INTRAVENTRICULAR FLUID STORAGE RESERVOIR (RE-2021) IMPLANTATION ON (B)(6) 2022, DUE TO INTRACRANIAL HEMORRHAGE AND WIDENING OF BILATERAL LATERAL VENTRICLES. 2 WEEKS AFTER THE SURGERY, THE IMAGING RE-EXAMINATION SHOWED VENTRICLE WIDENING, WHICH REQUIRED REGULAR DRAINAGE OF FLUID STORAGE RESERVOIR. THE CEREBROSPINAL FLUID RESERVOIR REPORTEDLY COLLAPSED WHEN PUMPING CEREBROSPINAL FLUID, RESULTING IN POOR PUMPING OF CEREBROSPINAL FLUID, UNABLE TO ACHIEVE THE THERAPEUTIC EFFECT. THIS TYPE OF ANOMALY WOULD SUGGEST AN OBSTRUCTION HAPPENING IN THE VENTRICULAR CATHETER LINKED TO THE DEVICE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269251 | SOPHYSA | PSO-PT | JXG | SOPHYSA | RE-2021 | F21091460/I046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Male | Other |