BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNTASSISTANT 2.0 20

    MDR report key: 14519567 · Received May 26, 2022

    Report

    Report Number
    2916714-2022-00051
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 26, 2022
    Manufacturer
    CHRISTOPH MIETHKE GMH & CO. KG
    Product Code
    JXG
    UDI-DI
    04041906501587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND QUALITY CONTROL DATA: BECAUSE THE SERIAL OR LOT NUMBER OF THE DEVICE IS UNKNOWN WE ARE NOT ABLE TO TRACE PRODUCTION AND QUALITY CONTROL DATA. WE CONFIRM ALL PARAMETERS HAVE BEEN INSPECTED AND APPROVED DURING THE MANUFACTURING. WE ASSURE THAT PRODUCTION AND QUALITY CONTROL ENSURE THAT ONLY PRODUCTS CONFORM TO SPECIFICATIONS ARE MADE AVAILABLE ON THE MARKET. CONCLUSION INFORMATION: AN INVESTIGATION WAS NOT POSSIBLE BECAUSE THE PRODUCT IS NOT AVAILABLE. WITH REFERENCE TO THE REASON FOR THE COMPLAINT, WE WOULD LIKE TO POINT OUT THAT DEPOSITS INSIDE THE VALVE COULD BE AFFECTED THE FUNCTIONAL IMPAIRMENT. DUE TO MISSING INFORMATION (PATIENT DATA, SERIAL NUMBER, DEVICE ITSELF), WE ARE UNABLE TO PROVIDE A MEANINGFUL ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHUNTASSISTANT 2.0 20 (PART # FX102T) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 TO EXPLANT A SHUNT ASSISTANT ALONG WITH ANOTHER MANUFACTURER'S VALVE. REPORTEDLY, WHEN THE NEW SHUNT ASSISTANT (PART # FV251T) (REF. MDR ID 2916714-2022-00052) WAS HOOKED UP TO A MANOMETER, THE VALVE DID NOT APPEAR TO WORK WITH THE MANOMETER. REPORTEDLY, IT DID NOT SHUT OFF WHEN IN THE UPRIGHT POSITION. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE EXPLANTED VALVE WAS ACCIDENTALLY DISPOSED OF BY THE HOSPITAL COORDINATOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. A FIVE (5) MINUTE DELAY WAS REPORTED AS A RESULT OF THE EVENT. IT IS THE SAME PATIENT AS MDR ID # 2916714-2022-00052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709562 SHUNTASSISTANT 2.0 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMH & CO. KG FX102T 04041906501587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention