BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE

    MDR report key: 3296084 · Received August 19, 2013

    Report

    Report Number
    1226348-2013-24251
    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 SECOND CASE INVOLVED A MALE INFANT WITH A LARGE INTRAPARENCHYMAL CYST ON THE LEFT PARIETAL PORTION. HE WAS INTUBATED FOR PNEUMONIA AT 1 MONTH OF AGE. HE HAD ASSOCIATED CONGENITAL HYDROCEPHALUS THAT WAS PROGRESSIVE, AND HE WAS TREATED WITH VP SHUNTING AT 69 DAYS OF AGE, AFTER HIS PNEUMONIA HAD RESOLVED. POSTOPERATIVE GMH WAS CONFIRMED, ALTHOUGH HYDROCEPHALUS WAS WELL CONTROLLED BY VP SHUNT INSERTION. OBSERVED CONSERVATIVELY, HE FARED WELL AND THE GMH RESOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401302 UNKNOWN VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention