BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV CYL W RR NU120CM DIST

    MDR report key: 2051125 · Received April 5, 2011

    Report

    Report Number
    1226348-2011-00127
    Event Type
    Injury
    Date Received
    April 5, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    020667
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION. AS A RESULT OF DEVICE AVAILABILITY THIS COMPLAINT HAS BEEN RE-OPENED AND INVESTIGATED. IT APPEARS THAT THE ROOT CAUSE OF THE PROBLEM COULD BE DUE TO A SHARP OBJECT COMING INTO CONTACT WITH THE CATHETER. AS NOTED IN THE INSTRUCTIONS FOR USE IS WARNS THE HEALTHCARE USERS TO USE EXTREME CARE WHEN HANDLING SILICONE PRODUCTS AS SILICONE HAS A LOW TEAR RESISTANCE. 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.

    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.

    Description of Event or Problem · 1

    PATIENT CALLED AND REPORTED THAT THE DISTAL CATHETER BROKE AND MIGRATED INTO THE ABDOMEN. HE SAID THAT ON (B)(6) 2010, HE WAS IMPLANTED WITH THE DEVICE. SEVEN DAYS LATER, THE DEVICE WAS ADJUSTED. ON (B)(6) 2011, SUBDURAL HEMATOMAS WERE EVACUATED. FOLLOWING THIS SURGERY, THERE WAS LEAKAGE NEAR THE SITE WHERE THE CATHETER HAD BEEN LIGATED FOLLOWING EVACUATION OF THE SUBDURAL HEMATOMA. REP EXPLAINED THAT HE HAD RECEIVED A CALL FROM THE SURGEON EXPLAINING THAT HE USED A STEEL LIGATURE CLIP TO CLOSE OFF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHPV CYL W RR NU120CM DIST SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention