BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE

    MDR report key: 3738473 · Received April 10, 2014

    Report

    Report Number
    1226348-2014-11358
    Event Type
    Injury
    Date Received
    April 10, 2014
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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 RETURNED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED THROUGH THE DEPUY HEALTHCARE WEBSITE EXPLAINING THAT THE PATIENT WROTE I AM SCHEDULED FOR VENTRICULOO ATRIAL SHUNT REDO 3/17 AFTER INITIAL V PERITONEAL PLACEMENT (B)(6) 2013. THE FIRST CATHETER WAS REJECTED INTO A SUB Q POCKET AFTER 2-3 WEEKS BUT WAS IGNORED UNTIL I WHINED ENOUGH IN (B)(6). XRAY CONFIRMED THAT THE CATHETER WAS COILED OUTSIDE THE PERITONEUM SO A SECOND SURGERY WAS REQUIRED IN (B)(6) 2014. AFTER TWO WEEKS THIS CATHETER WAS ALSO RECOILED INTO SUB Q POUCH, AND THE SHUNT IS NOT FUNCTIONING. SYMPTOMS OF COURSE RECUR AFTER EACH FAILURE. I AM TOLD THIS IS NOT (NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219138 UNKNOWN VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention