FDA Adverse Event
Injury
Summary report: N
STRATA 2, ADJUSTABLE VALVE, REGULAR
MDR report key: 1912336
·
Received November 5, 2010
Report
- Report Number
- 2021898-2010-00279
- Event Type
- Injury
- Date Received
- November 5, 2010
- Date of Event
- August 19, 2010
- Report Date
- October 9, 2010
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO VALID LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
MEDTRONIC NEUROSURGERY RECEIVED MAUDE REPORT# (B)(4) . IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED AND EXPLANTED THE SHUNT IN 2010. THE PHYSICIAN STATED THAT THE SHUNT WAS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA 2, ADJUSTABLE VALVE, REGULAR | JXG | MEDTRONIC NEUROSURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |