BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CODMAN EVD CATHETER

    MDR report key: 6597790 · Received May 30, 2017

    Report

    Report Number
    1226348-2017-10357
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    March 1, 2006
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, UDI UNAVAILABLE. 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 AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿CEFEPIME VS. AMPICILLIN/SULBACTAM AND AZTREONAM AS ANTIBIOTIC PROPHYLAXIS IN NEUROSURGICAL PATIENTS WITH EXTERNAL VENTRICULAR DRAIN: RESULT OF A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL¿ PUBLISHED JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS (2006) 31, 231¿235, IT WAS REPORTED THAT CSF INFECTIONS (14 IN GROUP A & 8 IN GROUP B) AND WOUND INFECTIONS (8 IN GROUP A AND 3 IN GROUP B) WERE REPORTED IN ASSOCIATION WITH THE USE OF THE CODMAN EVD CATHETERS. PER THE ARTICLE: ¿INTRODUCTION: WE AIMED TO FIND OUT WHETHER SINGLE BOARD SPECTRUM ANTIBIOTIC PROPHYLAXIS WAS AS GOOD AS DUAL SPECIFIC ANTIBIOTIC PROPHYLAXIS IN NEUROSURGICAL PATIENTS WITH EXTERNAL VENTRICULAR DRAIN (EVD) IN SITU. METHOD: IN A 2-YEAR PERIOD, 255 ELIGIBLE PATIENTS WERE RECRUITED. PATIENTS WERE RANDOMIZED INTO TWO GROUPS OF ANTIBIOTIC PROPHYLAXIS AS LONG AS THE VENTRICULAR CATHETER IN SITU. GROUP A EMPLOYED CEFEPIME 2G 12 HOURLY AND GROUP B EMPLOYED DUAL ANTIBIOTICS AS AMPICILLIN/SULBACTAM 3 G 8 HOURLY AND AZTRENAM 2 G 8 HOURLY. RESULTS: THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN CEREBROSPINAL FLUID (CSF) INFECTION RATE WITH 14 PATIENTS IN GROUP A (CEFEPIME PROPHYLAXIS) AND EIGHT PATIENTS IN GROUP B (DUAL PROPHYLAXIS WITH AMPICILLIN/SULBACTAM AND AZTRENAM) HAD CSF INFECTION. THERE WAS ALSO NO STATISTICAL SIGNIFICANT DIFFERENCE BETWEEN WOUND INFECTION RATE HAPPENED IN EIGHT PATIENTS IN GROUP A AND THREE PATIENTS IN GROUP B. THERE WAS NO STATISTICAL SIGNIFICANT DIFFERENCE IN EXTRACRANIAL INFECTION RATE BETWEEN BOTH GROUPS. CONCLUSION: SINGLE BOARD SPECTRUM ANTIBIOTIC PROPHYLAXIS WITH CEFEPIME WAS AN EFFECTIVE ALTERNATIVE REGIMEN FOR NEUROSURGICAL PATIENTS WITH AN EVD IN SITU.¿ AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, OR PATIENT SPECIFIC IDENTIFIERS IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379330 UNKNOWN CODMAN EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention