FDA Adverse Event
Injury
Summary report: N
MICRO PV W RICKHAM MH
MDR report key: 24910535
·
Received April 17, 2026
Report
- Report Number
- 3013886523-2026-00093
- Event Type
- Injury
- Date Received
- April 17, 2026
- Date of Event
- March 25, 2026
- Report Date
- April 17, 2026
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- PMA / PMN Number
- K221840
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
A FACILITY REPORTED A HAKIM VALVE (ID 823098) WAS IMPLANTED IN (B)(6) 2025. THE VALVE WAS OCCLUDED, THEREFORE, IT WAS REMOVED AND REPLACED ON (B)(6) 2026. THE PATIENT EXPERIENCED EMESIS, DECREASE ACTIVITY AND INCREASED SLEEPINESS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171838 | MICRO PV W RICKHAM MH | INTERNAL CSF DRAINAGE | JXG | INTEGRA LIFESCIENCES MANSFIELD | 5038024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |