BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT, CENTRAL NERVOUS SYSTEM, & COMPS

    MDR report key: 3113651 · Received May 15, 2013

    Report

    Report Number
    1226348-2013-16836
    Event Type
    Injury
    Date Received
    May 15, 2013
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Description of Event or Problem · 1

    ACCORDING TO A STUDY PUBLISHED THAT INVOLVED A (B)(6) BOY WHO HAD TECTAL PLATE LOW GRADE FLIOMA WITH OBSTRUCTIVE HYDROCEPHALUS WAS MANAGED WITH CODMAN PROGRAMMABLE VENTRICULOPERITONEAL SHUNT. THERE WAS A SPONTANEOUS CHANGE IN THE OPENING PRESSURE OF THE SHUNT VALVE LEADING TO SHUNT MALFUNCTION. ROUTINELY USED HOUSEHOLD APPLIANCE PRODUCE A MAGNETIC FIELD STRONG ENOUGH TO CAUSE CHANGE IN THE SETTING OF SHUNT VALVE PRESSURE AND MY LEAD TO VALVE MALFUNCTION. HE PRESENTED WITH INCREASED HEAD SIZE SINCE BIRTH, HEADACHE AND IMBALANCE WHILE WALKING FOR ONE MONTH. THE PATIENT GRADUALLY IMPROVED BOTH CLINICALLY AND RADIOLOGICALLY BEFORE HE WAS DISCHARGED. IMPROVEMENT CONTINUED FOR A MONTH AND A HALF. PATIENT PRESENTED WITH SYMPTOMS. SCAN INDICATED DILATED VENTRICLES. CSF TAPPED FROM THE BRAIN, WHICH LED TO TRANSIENT CLINICAL IMPROVEMENT. PATIENT CONTINUED TO PRESENT WITH SYMPTOMS AND IMPROVEMENTS UNTIL ULTIMATELY THE DEVICE WAS REVISED AS IT WAS DETERMINED THAT SOME HOUSE-HOLD ELECTRIC/ELECTRONIC APPLIANCE HAD LED TO A CHANGE IN THE PRESSURE OF THE SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214250 SHUNT, CENTRAL NERVOUS SYSTEM, & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention