FDA Adverse Event
Injury
Summary report: N
STRATA NSC, SMALL, BIOGLIDE
MDR report key: 1870860
·
Received October 7, 2010
Report
- Report Number
- 2021898-2010-00245
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 13, 2010
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K033850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE VALVE WAS PATENT AND PASSED REFLUX TESTING. THE VALVE PERFORMANCE MET ALL ESTABLISHED SPECS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. HOWEVER, THE VALVE FAILED LEAK TESTING DUE TO A PINHOLE IN THE SILICONE DOME NEXT TO THE FLOW DIRECTION ARROW. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR THAT ACCOMPANIES THE PRODUCT CAUTIONS THAT CARE SHOULD BE TAKEN IN HANDLING THE PRODUCT AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER IMPLANTATION OF THE VALVE, FLOW COULD NOT BE CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA NSC, SMALL, BIOGLIDE | JXG | MEDTRONIC NEUROSURGERY | NA | C56466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |