BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8095008 · Received November 21, 2018

    Report

    Report Number
    1226348-2018-10820
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    March 1, 2018
    Report Date
    October 29, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER. "MULITPLE" ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL. UDI UNAVAILABLE. 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, MRCS, DAVID ROWLAND, BMBCH, ANDREW JUDGE, PHD, AMEDEO CALISTO, PHD, JAYARATNAM JAYAMOHAN, FRCS, DAVID JOHNSON, FRCS, PETER RICHARDS, FRCS, SHAILENDRA MAGDUM, FRCS, AND STEVEN WALL, FCS(SA), PUBLISHED J NEUROSURG PEDIATR 21: 278¿283, 2018, HTTPS://THEJNS.ORG/DOI/ABS/10.3171/2017.9.PEDS17360, IT WAS REPORTED THAT AFTER IMPLANT OF CODMAN MICROSENSOR, 16 PATIENTS HAD HARDWARE FAILURE ISSUES, LEADING TO 9 ADDITIONAL INTERVENTIONS. 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.¿ OF THE 16 HARDWARE PROBLEMS, THE ICP MONITOR WIRE SNAPPED IN 4 PATIENTS, 2 PATIENTS HAD PROBLEMS WITH ICP MONITOR REMOVAL, AND THE REST WERE DUE TO INNATE PROBLEMS WITH THE ICP TRANSDUCER WIRE. NINE PATIENTS REQUIRED FURTHER OPERATIONS DUE TO HARDWARE PROBLEMS (8 PATIENTS HAD REPLACEMENT ICP MONITORS INSERTED, AND 1 PATIENT REQUIRED EXPLORATION AND REMOVAL OF WIRE UNDER GENERAL ANESTHESIA. AT THE TIME OF COMPLAINT ENTRY, NO PATIENT SPECIFIC OR DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS ARTICLE WAS DISCOVERED IN THE PMS REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935852 NI NI GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R