BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE

    MDR report key: 3296050 · Received August 19, 2013

    Report

    Report Number
    1226348-2013-24249
    Event Type
    Injury
    Date Received
    August 19, 2013
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RETURNED.

    Description of Event or Problem · 1

    ACCORDING TO A PUBLISHED ARTICLE POSTED IN THE J NEUROSURG: PEDIATRCIS/VOLUME 12/JULY 2013 IT WAS EXPLAINED THAT GERMINAL MATRIX HEMORRHAGES (GMHS) ARE TYPICALLY SEEN IN PRETERM NEONATES DURING THE FIRST 4 DAYS OF LIFE. THE AUTHORS ENCOUNTERED 2 CHILDREN WITH LATE-ONSET GMH SUBSEQUENT TO VENTRICULOPERITONEAL (VP) SHUNT INSERTION FOR CONGENITAL HYDROCEPHALUS. BOTH CHILDREN WERE DELIVERED AT FULL TERM WITH NORMAL BODY WEIGHT, ALTHOUGH THEY WERE COMPROMISED WITH THE PRECEDING HYPOXIC EVENTS PRIOR TO SHUNT INSERTION. THE FIRST CASE INVOLVED A FEMALE INFANT WITH SEVERE CRANIOFACIAL DEFORMITIES. BECAUSE OF ASPIRATION PNEUMONIA RELATED TO THE COMORBID UPPER AIRWAY STENOSIS, ENDOTRACHEAL INTUBATION WITH INTERMITTENT MECHANICAL VENTILATION WAS NECESSARY. THE ASSOCIATED CONGENITAL HYDROCEPHALUS WAS TREATED WITH VUP SHUNT INSERTION WHEN SHE WAS 35 DAYS OF AGE, AND GMH WAS CONFIRMED 1 WEEK AFTER SHUNT PLACEMENT. DURING A PERIOD OF CONSERVATIVE OBSERVATION, THE HEMORRHAGE RESOLVED WITHOUT ANY NEUROLOGICAL DETERIORATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401246 UNKNOWN VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention