FDA Adverse Event
Summary report: N
STRATA SNAP SHUNT ASSEMBLY, REGULAR
MDR report key: 977352
·
Received October 5, 2004
Report
- Report Number
- 2021898-2004-00138
- Date Received
- October 5, 2004
- Date of Event
- June 29, 2004
- Report Date
- September 16, 2004
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT AVAILABLE FOR RETURN TO THE MFR. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OUR PRODUCTS ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCT WAS EXPLANTED BECAUSE IT WAS NOT FUNCTIONING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA SNAP SHUNT ASSEMBLY, REGULAR | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JYG | MEDTRONIC NEUROSURGERY | NA | A33796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |