BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 11096874 · Received December 30, 2020

    Report

    Report Number
    3013886523-2020-00288
    Event Type
    Injury
    Date Received
    December 30, 2020
    Report Date
    December 10, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7,H2, H3, H6, H10. UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). THE VALVE WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND NO LOT NUMBER INFORMATION HAS 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.

    Description of Event or Problem · 0

    N/A.

    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

    A PHYSICIAN REPORTED THAT THE CERTAS INLIN VALVE (PRODUCT ID 828806) WAS IMPLANTED IN A PATIENT DUE TO IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) VIA L-P SHUNT IN 2019 WITH UNKNOWN SETTING. THE VALVE WAS USED WITH A LUMBAR CATHETER OF A DIFFERENT MANUFACTURER. WHEN THE EMBEDDED TOOL KIT (ETK) WAS USED ON THE SKIN DIRECTLY, THE SETTING COULD NOT BE CHANGED EXCEPT FOR 7 AND 8, AND IF THE SETTING WAS 8, THE PATIENT'S SYMPTOM BECAME WORSE. CONSEQUENTLY, THE PHYSICIAN SCHEDULED THE PATIENT FOR AN APPOINTMENT IN (B)(6) 2021 TO CHANGE THE SETTINGS TO 6 FOR BETTER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561856 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1