BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESCULAP SURGICAL INSTRUMENTS

    MDR report key: 9385751 · Received November 27, 2019

    Report

    Report Number
    2916714-2019-00126
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    May 25, 2019
    Report Date
    November 27, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    K161853 OR K141687; ALTHOUGH LEADING MATERIAL IS UNSPECIFIED, SAME OR SIMILAR MIETHKE PRODUCTS ARE UNDER THE PRECEEDING 510KS. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, WHEN AND IF NEW DATA IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN UNKNOWN SHUNT SYSTEM. IT WAS REPORTED THAT A VENTRICULOPERITONEAL (VP) SHUNT PROCEDURE WAS PERFORMED ON OR ABOUT (B)(6) 2019 WHEN AN ALREADY IMPLANTED PROGRAMMABLE SHUNT WAS REPLACED DUE TO A NON-SPECIFIED MALFUNCTION. THERE WAS REPORTEDLY NO DELAY DURING THE REVISION SURGERY AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181227 AESCULAP SURGICAL INSTRUMENTS HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG AESCULAP010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention