BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CERTAS TOOL KIT

    MDR report key: 4824005 · Received June 8, 2015

    Report

    Report Number
    1226348-2015-10330
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 14, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    I WANT TO INITIATE THE PRODUCT COMPLAINT PROCESS AROUND A CERTAS PLUS TMS UNIT (CODMAN PRODUCT CODE: 82-8851). ONE OF MY SURGEONS HAD DIFFICULTY INDICATING AND RE-PROGRAMMING A PATIENT WITH AN OLD CERTAS VALVE ON (B)(6) 2015. HE MENTIONED THAT HE DID NOT HAVE THE SAME CHALLENGE WITH HIS OLD RED TMS UNIT AND WAS HOPING TO GET ONE OF THESE BACK. THE PEDIATRIC PATIENT WAS KEPT SEVERAL HOURS LONGER THAN EXPECTED AS THEY ATTEMPTED TO LOCATE ANOTHER PURPLE PROGRAMMER. THE SURGEON WAS EVENTUALLY ABLE TO CORRECTLY INDICATE AND REPROGRAM THE PATIENTS VALVE ACCORDINGLY WITH A NEW TMS. I DID EXPLAIN THE REASON THAT WE REPLACED THIS WITH THE NEW PURPLE UNIT. ADDITIONALLY, I OFFERED ADDITIONAL TRAINING AROUND THE NEW TMS SYSTEM. (B)(6) 2015: I RECEIVED THIS CALL OF THE DIFFICULTY OF PROGRAMMING ON (B)(6). NO (ADVERSE CONSEQUENCES) OTHER THAN DELAY IN GETTING THEIR VALVE REPROGRAMMED. NO (SERIAL OR LOT NUMBER AVAILABLE). NO (DEVICE IS NOT BEING RETURNED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369428 CODMAN CERTAS TOOL KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1