BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK EVD

    MDR report key: 7169142 · Received January 5, 2018

    Report

    Report Number
    1226348-2018-10025
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    July 24, 2017
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE CONVERSION OF EXTERNAL VENTRICULAR DRAINAGE TO VENTRICULO-PERITONEAL SHUNT: CHANGE OR NOT TO CHANGE THE PROXIMAL CATHETER? PUBLISHED CHILDS NERV SYST (2017) 33:1947¿1952DOI 10.1007/S00381-017-3544- IT WAS REPORTED THAT PATIENT #18, A (B)(6)-YEAR-OLD MALE PRESENTED WITH DANDY-WALKER, TRAPPED 4TH VENTRICLE AND SHUNT INFECTION WITH THE INDICATION FOR SHUNT BEING INFECTION AND SD (SHUNT DEPENDENCE). APPROXIMATELY 30 DAYS POST INSERTION, THERE WAS A REPORTED INFECTION. PER THE ARTICLE ¿PURPOSE: IN THIS STUDY, WE INVESTIGATE THE OCCURRENCE RATE OF EARLY SHUNT INFECTION AND MALFUNCTION IN PEDIATRIC PATIENTS AFTER CONVERTING AN EXTERNAL VENTRICULAR DRAINAGE (EVD) TO A VENTRICULO-PERITONEAL SHUNT (VPS) WITHOUT REPLACING THE VENTRICULAR CATHETER. METHODS DATA WAS RETROSPECTIVELY REVIEWED FOR 17 PEDIATRIC PATIENTS (11 MALE (64.7%), MEAN AGE 7.5 YEARS, RANGE 0.25¿ 15 YEARS) WHO UNDERWENT 18 CONSECUTIVE DIRECT CONVERSIONS OF TUNNELED EVD TO VPS WITHOUT REPLACING THE VENTRICULAR CATHETER BETWEEN 2008 AND 2017. IN EACH CASE, THE EVD WAS INSERTED IN STERILE FASHION WITHIN THE OPERATING ROOM AND TUNNELED SUBCUTANEOUSLY 5¿7 CM AWAY FROM THE INSERTION SITE. PRIMARY OUTCOME MEASURE WAS THE OCCURRENCE OF EARLY (WITHIN 30 DAYS) VPS INFECTION OR MALFUNCTION. THE MEAN FOLLOW-UP TIME WAS 56.8 MONTHS (±35.7 MONTHS) ¿. CONCLUSION IN THE PEDIATRIC POPULATION, THE CONVERSION OF A TUNNELED EVD TO A VPS WITHOUT REPLACING THE VENTRICULAR CATHETER CAN BE SAFELY DONE.¿ ALSO PER THE ARTICLE: ¿EARLY SHUNT INFECTION OCCURRED IN ONE PATIENT (5.6%) AFTER 30 DAYS. THIS PATIENT PRESENTED AT AN EARLY AGE WITH AN INFECTED SHUNT (ESCHERICHIA COLI AND CANDIDA) 4 YEARS AFTER SHUNT PLACEMENT (THE SHUNT WAS ORIGINALLY INSERTED DUE TO A TRAPPED 4TH VENTRICLE IN ASSOCIATION WITH A DANDY WALKER MALFORMATION). THE SHUNT WAS EXTERNALIZED, ANTIBIOTIC AND ANTIFUNGAL MEDICATION WAS ADMINISTERED, AND ONCE CULTURES WERE NEGATIVES, IT WAS REPLACED BY A NEW SHUNT SYSTEM. TWO YEARS LATER, THE PATIENT PRESENTED WITH SUSPECTED ABDOMINAL INFECTION. THE SHUNT WAS EXTERNALIZED, AND ONCE PROVEN INFECTED ((B)(6))), THE SHUNT WAS REMOVED AND AN EVD WAS PLACED. AFTER OBTAINING STERILE CSF CULTURES, THE EVD WAS CONVERTED AFTER 8 DAYS TO A VENTRICULO-ARTRIAL SHUNT (VAS). THIRTY DAYS LATER, THE PATIENT PRESENTED WITH FEVER AND NEUROLOGICAL DECLINE CAUSED BY AN (B)(6) SHUNT INFECTION. THE SHUNT WAS EXTERNALIZED AND THE PATIENT TREATED WITH ANTIBIOTICS UNTIL THE CSF WAS STERILE. A NEW VPS WAS THEN IMPLANTED. THERE WERE NO FURTHER INFECTIONS IN THIS PATIENT DURING SUBSEQUENT FOLLOW-UP.¿ AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12314 UNK EVD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention