FDA Adverse Event
Malfunction
Summary report: N
SOPHY SM8A KIT PREATTACHED/BO19-10
MDR report key: 2941614
·
Received December 20, 2012
Report
- Report Number
- 3001587388-2012-00475
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- November 22, 2012
- Report Date
- December 19, 2012
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE VALVE WILL BE ANALYZED BY SOHPYSA AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
SM8A WAS IMPLANTED IN THE PT IN 2007. ON (B)(6) 2012, SHE UNDERWENT A BRAIN TUMOR REMOVAL OPERATION. THE VALVE FUNCTIONED PROPERLY AFTER THE OPERATION TOO. HOWEVER, DURING MRI SCAN ON (B)(6), THE PRESSURE SETTING AUTOMATICALLY CHANGED FROM 30 TO 200. THE SURGEON TRIED TO RE-ADJUST IT TO 30 BUT HE COULD NOT. SINCE THE PT STARTED TO SUFFER FROM THE VENTRICULAR ENLARGEMENT, HE EXTRACTED THE VALVE AND IMPLANTED A NEW SM8A. PLEASE EXAMINE THE SAMPLE TO SEE IF THE PRESSURE SETTING CAN BE CHANGED SMOOTHLY. THE CUSTOMER ALSO WOULD LIKE TO KNOW THE ROOT CAUSE OF THE DIFFICULTY IN CHANGING AND THE MEASURE VALUES OF EACH PRESSURE POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOPHY SM8A KIT PREATTACHED/BO19-10 | SOPHY SM8A KIT PREATTACHED/BO | JXG | SOPHYSA | SOPHI MINI ADJU | Y0495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |