BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE VALVE ONLY

    MDR report key: 18664029 · Received February 7, 2024

    Report

    Report Number
    3013886523-2024-00015
    Event Type
    Injury
    Date Received
    February 7, 2024
    Report Date
    April 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780521013
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DHR - LOT6814550, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. ADDITIONAL INFORMATION RECEIVED: NAME: (B)(6) 60 YEARS OLD/ FEMALE, DOB: (B)(6) 1962, DATE OF OPERATION: (B)(6) 2023, DATE: (B)(6) 2023, PREOPERATIVE DX: COMMUNICATING HYDROCEPHALUS, POST-OP DIAGNOSIS: COMMUNICATING HYDROCEPHALUS , PROCEDURE(S) (LRB): REVISION OF VP SHUNT (RIGHT). FINDINGS: RIGHT SIDED VP SHUNT REVISION, NON-FUNCTIONING VALVE, REPLACEMENT WITH A CODMAN CERTAS VALVE WITH NO ANTISIPHON SET TO 3, GOOD FLOW FROM THE PROXIMAL CATHETER, GOOD FLOW DOWN TO 4 CM H20 WITH THE DISTAL CATHETER. SPECIMEN(S) REMOVED/DISPOSITION: * NO SPECIMENS IN LOG. COMPLICATIONS: NONE. DRAINS: NONE. DISPOSITION: PACU - STABLE.

    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.

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE OF THE REPORTED ISSUE 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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THIS IS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00189. 3013886523-2024-00028. A PATIENT REPORTED A CERTAS VALVE WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, SHUNT WAS SET AT 5. ON (B)(6), 2023, THE SHUNT WAS CHECKED AT 4, AND WAS SET AGAIN TO 5. ON (B)(6) 2023, THE SHUNT WAS CHECKED, AND FOUND AT 4 AGAIN, THEN SET TO 6. ON (B)(6) 2023, THE SHUNT WAS CHECKED AND FOUND AT 2, THEREFORE IT WAS SET TO 5 AGAIN. ON (B)(6) 2023, A NEW SHUNT WAS PLACED, AND WAS SET ON 4. THE PATIENT IS CURRENTLY FINE WHEN SITTING OR RESTING. HOWEVER, STILL DIZZY AND NAUSEATED WHEN GETTING UP. THE FIRST SHUNT WAS PLACED ON (B)(6) 2023 WHICH WAS FOUND TO BE DEFECTIVE. THE SECOND SHUNT WAS PLACED ON (B)(6) 2023 AND WAS ALSO DEFECTIVE. THE THIRD SHUNT WAS PLACED ON (B)(6) 2023.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192807 CERTAS PLUS INLINE VALVE ONLY CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 6814550 10381780521013

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female