FDA Adverse Event
Injury
Summary report: N
STRATA 2 VALVE, SMALL, BIOGLIDE
MDR report key: 3250069
·
Received July 26, 2013
Report
- Report Number
- 2021898-2013-00251
- Event Type
- Injury
- Date Received
- July 26, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 26, 2013
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS EXPLANTED AS IT COULD NOT BE ADJUSTED. ACCORDING TO THE REPORT, THE PHYSICIAN TRIED TO CHANGE THE PRESSURE SETTING, HOWEVER, WAS UNABLE TO DO SO DUE TO OCCLUSION WITHIN THE VALVE. THE REPORT STATED THAT THE PATIENT DID NOT SHOW ANY SYMPTOMS, HOWEVER, THE PHYSICIAN DECIDED TO EXPLANT THE VALVE AND REPLACE IT WITH A CODMAN HAKIM VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349883 | STRATA 2 VALVE, SMALL, BIOGLIDE | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00008 YR | Hospitalization| R |