BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 11166860 · Received January 13, 2021

    Report

    Report Number
    3013886523-2021-00021
    Event Type
    Injury
    Date Received
    January 13, 2021
    Report Date
    December 28, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D10, G1, G4, G7,H2, H3, H4, H6, H10. UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). THE VALVE WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE). THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. 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

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED AN ISSUE WITH A CERTAS VALVE: THE VALVE WAS IMPLANTED VIA L-P SHUNT ON AN UNKNOWN DATE WITH SETTING 4 AND WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ) AND A BACTISEAL CATHETER (NS0339). ON DECEMBER 28, 2020, WHEN THE SETTING WAS ATTEMPTED TO CHANGE FROM 4 TO 3 BY ETK, IT COULD NOT BE CHANGED AND THE BLACK DOT WAS DISAPPEARING AFTER DISPLAYED. WITH THE CERTAS TOOL KIT, THE SETTING COULD BE CONFIRMED, BUT COULD NOT BE CHANGED. THE PATIENT IS FOLLOWING UP, HOWEVER, IF THE SETTING NEED TO BE CHANGED, THE VALVE WILL BE REPLACED. ADDITIONAL INFORMATION RECEIVED ON JANUARY 11, 2021 STATES THAT THE VALVE IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60381 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5039415

    Patients

    Seq Age Sex Outcome Treatment
    1 BACTISEAL CATHETER (NS0339).| SILASCON LUMBAR CATH.MANUF BY KANEKA,CODE: 702-JJ.