BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG 823832

    MDR report key: 24844446 · Received April 10, 2026

    Report

    Report Number
    3013886523-2026-00085
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 PROGRAMMABLE VALVE (ID: 823832) WAS IMPLANTED ON (B)(6) 2026 VIA VENTRICULOPERITONEAL SHUNT. RECENTLY, SUBCUTANEOUS FLUID ACCUMULATION NEAR THE VALVE SITE RECURRED ALONG WITH HYDROCEPHALUS SYMPTOMS. ON (B)(6) 2026, EXPLORATORY CRANIOTOMY REVEALED FRACTURE AT THE JUNCTION BETWEEN THE VALVE AND ANTI-SIPHON DEVICE, PROMPTING IMMEDIATE REVISION SURGERY WITH REIMPLANTATION OF 823832 SHUNT SYSTEM. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452093 PROG VALVE INLINE W SG 823832 INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD 7302942 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1