FDA Adverse Event
Malfunction
Summary report: N
STRATA 2, ADJUSTABLE VALVE, REGULAR
MDR report key: 2061445
·
Received March 16, 2011
Report
- Report Number
- 2021898-2011-00056
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 22, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE VALVE WAS PATENT. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR SIPHON AND LEAK TESTING DUE TO A TEAR IN THE TOP AND BOTTOM OF THE DELTA CHAMBER. THIS DAMAGE PRECLUDED REFLUX AND PRESSURE-FLOW AND PREIMPLANTATION TESTING. IT IS UNKNOWN HOW OR WHEN THESE DAMAGES OCCURED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO PATIENT REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING PREIMPLANTATION TESTING, THE DELTA CHAMBER WAS FOUND LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA 2, ADJUSTABLE VALVE, REGULAR | JXG | MEDTRONIC NEUROSURGERY | NA | C64455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |