BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VENTICULAR & PERITONEAL CATHETERS WITH BACTISEAL

    MDR report key: 3833754 · Received May 27, 2014

    Report

    Report Number
    1226348-2014-11672
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    March 24, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK003322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. -REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE DEVICE CONFORMED TO THE SPECIFICATIONS PRIOR TO DISTRIBUTION. THIS COMPLAINT IS CONSIDERED CLOSED. COMPLAINT SAMPLE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP IS BEING FILED TO POPULATE SINCE IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION; THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    A FOLLOW UP IS BEING FILED TO POPULATE SINCE IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION; THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    (B)(4). BACTISEAL SHUNT SYSTEM, LOT CPPBFO (USED IN CONJUNCTION WITH MEDTRONIC VALVE) PATIENT HAS A HIGH BMI, PRIMARY SHUNT PROCEDURE. (B)(6). DATE OF SURGERY: (B)(6) 2014. DATE REPORTED: (B)(4) 2014. NO PRODUCT TO BE RETURNED. (B)(4) 2014 ADDITIONAL INFORMATION FROM THE AFFILIATE EXPLAINED THAT, "I SPOKE WITH THE NEURO CONSULTANT WHO REPORTED THESE CASES LAST FRIDAY, (B)(6), LEAD CLINICIAN IN THE HOSPITAL. HE ADVISED THAT BOTH PATIENTS HAVE SETTLED DOWN AND ARE NO LONGER SHOWING SYMPTOMS OF INFECTION AS WAS PREVIOUSLY REPORTED. HE IS VERY SURPRISED HIMSELF. HE HAS ADVISED THAT LAB RESULTS HAVE SHOWED NO BACTERIA GROW FOR ONE OF THE PATIENTS AND HE BELIEVES ALSO THE SECOND. HE IS GOING TO CHECK IT OUT AND REPORT BACK. I WILL BE IN TOUCH. HE SEEMS FAIRLY HAPPY WITH BOTH PATIENTS AT PRESENT. NO REVISION SURGERY IS THEREFORE PLANNED AT THE MOMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310242 HAKIM VENTICULAR & PERITONEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPPBF0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention