BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 6709255 · Received July 12, 2017

    Report

    Report Number
    1226348-2017-10490
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 22, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 7. THE VALVE WAS VISUALLY INSPECTED: THE SILICONE HOUSING AROUND THE SIPHON GUARD WAS CUT/TORN. THIS HAS MOST PROBABLY HAPPENED DURING IMPLANTATION OF THE VALVE. A SEARCH FOR RELATIVE COMPLAINT FOR THE SAME ISSUE WITH THE SAME PRODUCT CODE FOR THE LAST YEAR REVEALED THAT THIS IS THE ONLY ISSUE. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE PRODUCT CODE 82-8804, WITH LOT 122337, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 8TH MARCH 2017. THE ROOT CAUSE FOR THE TEAR/CUT IN THE SILICONE HOUSING IS PROBABLY DUE TO THE USER, THIS HOWEVER COULD NOT BE DETERMINED. AS NOTED IN THE IFU SILICONE HAS A LOW TEAR / CUT RESISTANCE. PER HHE, IT HAS BEEN CONCLUDED THAT SILICONE HOUSING TEARS ARE NOT DESIGN RELATED, IN ORDER FOR THE HOUSING TEAR TO OCCUR THE USER HAS TO COMPROMISE THE SILICONE THROUGH A NICK OR TEAR IN ORDER FOR THE EVENT TO OCCUR. VALIDATION TESTING DEMONSTRATES A ROBUST DESIGN. TESTING HAS SHOWN THAT IF THE SILICONE HOUSING HAS BEEN COMPROMISED, A HOUSING TEAR IS LIKELY TO OCCUR. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE REPORTED VALVE WAS IMPLANTED TO A PATIENT VIA LP-SHUNT (DOI AND INITIAL SETTING ARE UNKNOWN). IT WAS REPORTED THAT THE SURGEON FOUND THE SIPHON GARD WAS DETACHED FROM THE VALVE SO THAT THE EXPLANTING SURGERY WAS PERFORMED ON (B)(6) 2017. THE PATIENT IS (B)(6) YEARS OLD, FEMALE AND HER INITIAL IS (B)(6). THE PATIENT'S PRIMARY DISEASE IS SAH AND HER CONDITION IS UNDER MONITORING. THE SALES FORCE SCHEDULED AN INTERVIEW THE SURGEON AND WILL COLLECT MORE DETAIL. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485611 CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. 122337

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention