BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 10280907 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00300
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    May 22, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10 THE DEVICE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. THE POSSIBLE ROOT CAUSES FOR INFECTION COULD BE DUE TO INADEQUATE SILICONE HOUSING DIMENSIONS OR SILICONE BACKING TOO THICK OR LINKED TO THE IMPLANTATION PROCEDURE.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 1226348-2020-00299. A FACILITY REPORTED INTRACRANIAL INFECTION: THE PATIENT WAS IMPLANTED WITH 823114 (MICRO CHPV UNITIZED) AND 823072 (BACTISEAL CATHETER KIT) ON (B)(6) 2020, A WEEK LATER THE PATIENT WAS FOUND WITH INTRACRANIAL INFECTION, POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. ON (B)(6) 2020, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE TO RETRIEVE THE VALVE AND CATHETER. THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738558 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR