FDA Adverse Event
Injury
Summary report: N
PROG VALVE MICRO
MDR report key: 24278712
·
Received February 6, 2026
Report
- Report Number
- 3013886523-2026-00022
- Event Type
- Injury
- Date Received
- February 6, 2026
- Date of Event
- January 16, 2026
- Report Date
- May 8, 2026
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- UDI-DI
- 10886704041474
- PMA / PMN Number
- K221840
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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
IT WAS REPORTED THAT DURING THE FOLLOW-UP X-RAY EXAMINATION, THE MEDICAL STAFF VERIFIED THAT THE VENTRICLES WERE DILATED AND THAT THE VALVE (ID 823112) REQUIRED REPROGRAMMING. THEY ATTEMPTED TO REPROGRAM THE VALVE SEVERAL TIMES AND USING DIFFERENT PROGRAMMERS WITHOUT SUCCESS. ON (B)(6) 2026, A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE VALVE (WITHOUT REPLACEMENT OF THE CATHETERS), AND A CERTAS VALVE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183337 | PROG VALVE MICRO | INTERNAL CSF DRAINAGE | JXG | INTEGRA LIFESCIENCES MANSFIELD | 3224486 | 10886704041474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Unknown | Required Intervention |