FDA Adverse Event
Injury
Summary report: N
CSF-SHUNT SNAP ASSEMBLY, BUTTON, MEDIUM PRESSURE
MDR report key: 117825
·
Received September 3, 1997
Report
- Report Number
- 2021898-1997-00062
- Event Type
- Injury
- Date Received
- September 3, 1997
- Report Date
- August 6, 1997
- Manufacturer
- MEDTRONIC PS MEDICAL
- Product Code
- JXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SNAP SHUNT DISCONNECTED A FEW MONTHS AFTER SURGERY. THE DISCONNECTION WAS ATTRIBUTED TO THE GROWTH OF THE BABY. SHUNT WAS NOT EXPLANTED; WAS RE-SNAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSF-SHUNT SNAP ASSEMBLY, BUTTON, MEDIUM PRESSURE Implant | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JXG | MEDTRONIC PS MEDICAL | NA DEVICE 1 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization| R |