BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE VALVE 120CM

    MDR report key: 18664026 · Received February 7, 2024

    Report

    Report Number
    3013886523-2024-00028
    Event Type
    Injury
    Date Received
    February 7, 2024
    Report Date
    April 3, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780521136
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION AND 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. NO ROOT CAUSE NEEDED AS: ¿THERE IS CURRENTLY NO COMPLAINT FOR THE THIRD SHUNT PLACED ON (B)(6) 2023¿. 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.

    Additional Manufacturer Narrative · 0

    DHR - LOT 7174255, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. ADDITIONAL INFORMATION RECEIVED: (BRIEF OPERATIVE NOTE) NAME: (B)(6) IS A 60 YEARS OLD. FEMALE. OB: (B)(6) 1962. DATE OF OPERATION: (B)(6) 2023 . PREOPERATIVE DIAGNOSIS: VP (VENTRICULOPERITONEAL) SHUNT STATUS, OBSTRUCTIVE HYDROCEPHALUS POST-OP DIAGNOSIS: VP (VENTRICULOPERITONEAL) SHUNT STATUS, OBSTRUCTIVE HYDROCEPHALUS PROCEDURE(S) (LRB): REPLACEMENT/REVISION CEREBROSPINAL FLUID SHUNT SYSTEM - VENTRICULOPERITONEAL (RIGHT) FINDINGS: FUNCTIONING PROXIMAL CATHETER, REPLACED VALVE AND DISTAL CATHETER. ESTIMATED BLOOD LOSS: NO BLOOD LOSS DOCUMENTED. SPECIMEN(S) REMOVED/DISPOSITION: NO SPECIMENS IN LOG COMPLICATIONS: NONE0 DISPOSITION: ICU - STABLE.

    Description of Event or Problem · 0

    THIS IS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00189. 3013886523-2024-00015. 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 WITH SETTING 4. THERE IS CURRENTLY NO COMPLAINT FOR THE THIRD SHUNT. THE PATIENT WAS FINE WHEN SITTING OR RESTING; HOWEVER, SHE EXPERIENCED DIZZINESS AND NAUSEA WHEN GETTING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192804 CERTAS PLUS INLINE VALVE 120CM CERTAS PLUS W/ BACTISEAL JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 7174255 10381780521136

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female