BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7873771 · Received September 13, 2018

    Report

    Report Number
    1226348-2018-10644
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    October 3, 2018
    Report Date
    August 21, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. CORRECTED FIELDS: DEVICE AVAILABLE FOR EVALUATION. IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO PRODUCT OR 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿INTRA-VENTRICULAR MIGRATION OF A SUBCUTANEOUS RESERVOIR AFTER NEUROENDOSCOPY¿ BY DANIELA FALK & MARCUS O. PINSKER & H. MAXIMILIAN MEHDORN & ARYA NABAVI, PUBLISHED CHILDS NERV SYST (2017) 33: 2079¿2080, DOI 10.1007/S00381-017-3606-8, IT WAS REPORTED THAT AN UNKNOWN RICKHAM RESERVOIR MIGRATED AFTER IMPLANTATION AND WAS REVISED. PER THE ARTICLE: ¿THE PLACEMENT OF A SUBCUTANEOUS RESERVOIR FOR PRIMARY TREATMENT OF DIFFERENT TYPES OF HYDROCEPHALUS IN INFANTS IS AN EFFECTIVE AND SAFE METHOD. COMPLICATIONS ARE RARE. INTRAVENTRICULAR MIGRATION OF A RESERVOIR IS RARE AND ASSOCIATED WITH FURTHER SURGERIES¿ A (B)(6) GIRL WAS BORN VIA C-SECTION AND IN THE FIRST DAYS OF LIFE, A COMPLEX BRAIN MALFORMATION WITH HEMORRHAGE, HYDROCEPHALUS AND SEPARATION OF THE FOURTH VENTRICLE WAS DIAGNOSED¿TWENTY DAYS POST-PARTUM, AN ENDOSCOPIC SEPTOVENTRICULOSTOMY WAS PERFORMED¿. A SUBCUTANEOUS RICKHAM RESERVOIR WAS PLACED OVER THE BURR HOLE¿.AN MRI 2 MONTH AFTER SURGERY SHOWED ACCURATE PLACEMENT OF THE RESERVOIR¿.FOUR MONTHS LATER, THE SEIZURES INCREASED. CT SCAN DOCUMENTED A MIGRATION OF THE ENTIRE SUBCUTANEOUS RESERVOIR FROM THE RIGHT FRONTAL BURR-HOLE THROUGH THE POSTERIOR PART OF THE LATERAL VENTRICLE¿.IN THIS SPECIFIC CASE, WE CONSIDER THE MECHANISM TO BE SIMPLER, EVEN THOUGH THE DIAMETER OF THE BURR HOLE WAS SMALLER THAN THE BASE OF THE RICKHAM, IT IS MOST LIKELY THAT DUE TO THE PLASTICITY OF THE CHILD¿S SKULL, THE COUNTER PRESSURE WAS NOT ENOUGH.¿ 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
    715399 NI SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO