BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8374866 · Received February 27, 2019

    Report

    Report Number
    1226348-2019-10133
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    March 1, 2018
    Report Date
    February 5, 2019
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COMPLICATIONS FOLLOWING INTRACRANIAL PRESSURE MONITORING IN CHILDREN: A 6-YEAR SINGLE-CENTER EXPERIENCE.¿ BY RUICHONG MA, DAVID ROWLAND, ANDREW JUDGE, AMEDEO CALISTO, JAYARATNAM JAYAMOHAN , DAVID JOHNSON, PETER RICHARDS, SHAILENDRA MAGDUM AND STEVEN WALL, PUBLISHED JOURNAL OF NEUROSURGERY: PEDIATRICS. 21 (3) (PP 278-283), 2018, IT WAS REPORTED THAT 4.2% OF 385 MICROSENSOR CASES HAD HARDWARE FAILURE AND REQUIRED FURTHER SURGERY AS A RESULT. PER THE ARTICLE: ¿INTRACRANIAL PRESSURE (ICP) MONITORING IS AN IMPORTANT TOOL IN THE NEUROSURGEON'S ARMAMENTARIUM AND IS USED FOR A WIDE RANGE OF INDICATIONS. THERE ARE MANY DIFFERENT ICP MONITORS AVAILABLE, OF WHICH FIBER-OPTIC INTRAPARENCHYMAL DEVICES ARE VERY POPULAR. HERE, THE AUTHORS DOCUMENT THEIR EXPERIENCE PERFORMING ICP MONITORING FROM 2005 TO 2015 AND SPECIFICALLY COMPLICATION RATES FOLLOWING INSERTION OF THE MICROSENSOR ICP MONITOR. METHOD(S): A RETROSPECTIVE CASE SERIES REVIEW OF ALL PATIENTS WHO UNDERWENT ICP MONITORING OVER A 10-YEAR PERIOD FROM 2005 TO 2015 WAS PERFORMED. RESULT(S): THERE WERE 385 SEPARATE OPERATIONS WITH AN OVERALL COMPLICATION RATE OF 8.3% (32 OF 385 CASES).¿ THERE WERE NO SPECIFIC DEVICE FAILURES REPORTED, NOR THE EXACT SURGICAL INTERVENTION THAT WAS PERFORMED. AT THE TIME OF COMPLAINT ENTRY, NO PATIENT OR DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER. THIS ARTICLE WAS DISCOVERED THROUGH THE MONTHLY LITERATURE SEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166449 NI NI GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other