BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS THERAPY MGMT SYSTEM

    MDR report key: 3790060 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11477
    Event Type
    Injury
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A SERIOUS INJURY. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE SURGEON STATED THAT HE HAD A HARD TIME VERIFYING THE CORRECT SETTING WITH THE CERTAS INDICATOR TOOL AND SO THEY TOOK THE PATIENT FOR AN XRAY. ONCE IN XRAY, THEY HAD A DIFFICULT TIME READING THE VERIFICATION MARKERS ON THE XRAY TO DETERMINE IF THE VALVE WAS SET PROPERLY. HE WOULD LIKE A STONGER MARKERS- AS HE STATED "AS BRIGHT AS CHPV" SO ITS EASY TO KNOW THE ORIENTATION. DEVICE HAS NOT BEEN REVISED. 3/1 CLARIFICATION FROM THE REP EXPLAINED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON WAS EVENTUALLY ABLE TO GET THE READING HE WAS LOOKING FOR. DEVICE IS STILL IMPLANTED. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268551 CERTAS THERAPY MGMT SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 82-8804