BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK EVD

    MDR report key: 7168530 · Received January 5, 2018

    Report

    Report Number
    1226348-2018-10022
    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.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE CONVERSION OF EXTERNAL VENTRICULAR DRAINAGE TO VENTRICULO-PERITONEAL SHUNT: TO 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 #10, A (B)(6) FEMALE PRESENTED WITH CROUZON, ENCEPHALOCELE AND CONGENITAL HCP (HYDROCEPHALUS) WITH THE INDICATION OF SD (SHUNT DEPENDENCY). APPROXIMATELY 9 MONTHS POST INSERTION, IT WAS REPORTED THAT THE SYSTEM BECAME INFECTED. 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: ¿LATE SHUNT INFECTION OCCURRED IN ONE PATIENT (5.6%) AFTER 9 MONTHS. THIS PATIENT SUFFERED FROM CROUZON SYNDROME AND UNDERWENT A LEFORT DISTRACTION AT THE AGE OF 11 YEARS AND AN ENDOSCOPIC TRANS-NASAL REPAIR OF A BASAL ENCEPHALOCELE AND EVD PLACEMENT AT THE AGE OF 13 YEARS. THE EVD WAS CONVERTED INTO A SHUNT AFTER 6 DAYS, SINCE THE PATIENT BECAME EVD DEPENDENT. NINE MONTHS LATER, THE PATIENT PRESENTED WITH A TRANS-NASAL CSF RHINORRHEA AND STREPTOCOCCUS PNEUMONIA MENINGITIS. THE LEAK WAS TREATED SURGICALLY, WHILE THE VP SHUNT WAS EXTERNALIZED AND THE PATIENT TREATED WITH ANTIBIOTICS. ONCE THE CSF CULTURES SHOWED NO BACTERIAL GROWTH, THE VPS WAS REINSERTED INTO THE ABDOMEN. 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
    11325 UNK EVD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention