FDA Adverse Event
Injury
Summary report: N
DELTA VALVE, REGULAR, LEVEL 2.0
MDR report key: 1915675
·
Received December 1, 2010
Report
- Report Number
- 2021898-2010-00331
- Event Type
- Injury
- Date Received
- December 1, 2010
- Report Date
- November 2, 2010
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K902783
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE. AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. NO IMPACT TO THE PT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT RETURNED AFTER SURGERY WITH SYMPTOMS OF SHUNT OVERDRAINAGE WHEN STANDING UP. THE NEUROSURGEON CONFIRMED THAT THE ICP DROPPED DOWN TO NEGATIVE NUMBERS JUST A FEW MINUTES AFTER THE PT STOOD UP. THE DEVICE WAS EXPLANTED AND CHANGED FOR ANOTHER PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA VALVE, REGULAR, LEVEL 2.0 | JXG | MEDTRONIC NEUROSURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |