BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CERTAS VALVE

    MDR report key: 6654608 · Received June 20, 2017

    Report

    Report Number
    1226348-2017-10419
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    March 14, 2007
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE, UDI UNAVAILABLE. 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

    IN THE LITERATURE ARTICLE ¿SMARTPHONES AND PROGRAMMABLE SHUNTS: ARE THESE INDISPENSABLE PHONES SAFE AND SMART?¿ PUBLISHED WORLD NEUROSURG. (2017) 102:518-525, HTTP://DX.DOI.ORG/10.1016/J.WNEU.2017.03.054, IT WAS REPORTED THAT AN UNKNOWN CERTAS VALVE HAD PERMANENT PROGRAMMING CHANGES AFTER EXPOSURE TO MAGNETIC FIELDS. PER THE ARTICLE: ¿OBJECTIVE: THIS STUDY AIMED TO DETERMINE WHETHER SMARTPHONES AFFECT PROGRAMMABLE SHUNTS. METHODS: IPHONE 5S (APPLE INC., (B)(4)) AND SAMSUNG GALAXY S5 (SAMSUNG ELECTRONICS, (B)(4)) SMARTPHONES WERE CHOSEN FOR THIS STUDY. FOR BOTH PHONES, MAGNETIC FIELD MAPPING WAS PERFORMED WITH 3-DIMENSIONAL MAGNETIC SCANNING SYSTEMS CONSTRUCTED WITH HIGH-PRECISION MOTORIZED STAGES, AND A HALL EFFECT SENSOR WAS USED TO MEASURE THE FLUX DENSITY ON THE SMARTPHONE SURFACE. THE DISTANCE (H) BETWEEN THE DISTAL OUTLET OF THE RESERVOIR AND THE RUGBY BALL OF THE STRATA VALVE (MEDTRONIC INC., (B)(4)) WAS MEASURED USING HIGHLY SENSITIVE MICROANALYSIS OPTICAL METHOD. DURING OPTICAL MICROANALYSIS, WHILE KEEPING A 3-CM DISTANCE BETWEEN THE VALVE AND THE MAGNETIC GENERATOR, THE H VALUE (MM) WAS RECORDED FOR DIFFERENT MAGNETIC FLUX DENSITIES (MFDS). THEN, DIRECT X-RAY RADIOGRAPHY WAS PERFORMED FOR RADIOLOGIC ASSESSMENT AFTER EACH PROCESS UNDER DIFFERENT MAGNETIC FIELDS. FOR ANALYSIS OF THE CODMAN CERTAS VALVE (CODMAN NEURO, (B)(4)), THE MAGNET ORIENTATION AND THE ANGLE BETWEEN THE MAGNET WITH THE TANTALUM BALL WERE MEASURED WITH THE SAME OPTICAL ANALYSIS. RESULTS: MAXIMUM MFDS FOUND 62 G FOR IPHONE 5S AND 61 G FOR SAMSUNG GALAXY S5. WHEN THE MAGNETIC GENERATOR FORMED A CURRENT AT 0, 30, 60, AND 90 G, THE H VALUES OF THE STRATA VALVE ADJUSTED TO 100 MM H2O OPENING PRESSURE WERE 320, 280, 190, AND 175 MM, RESPECTIVELY. WHEN THE MAGNETIC GENERATOR WAS REMOVED FROM THE ENVIRONMENT, THE H VALUE RETURNED TO 320 MM. IN DIRECT GRAPHS TAKEN AFTER EACH OPTICAL ANALYSIS AT DIFFERENT GAUSS VALUES SUBSTITUTION WAS NOT OBSERVED AT THE INDICATOR. THE ANGLE IN THE CODMAN CERTAS VALVE WAS 123.9_, 112.5_, AND 103.6_ AT THE MAGNETIC FLUX DENSITIES OF 0, 60, AND 90 G, RESPECTIVELY. WHEN THE MAGNETIC FIELD WAS REMOVED (0 G), THE ANGLE WAS STILL 103.6_, SUGGESTING AN IRREVERSIBLE EFFECT IN THE SHUNT CONSTRUCT. CONCLUSIONS: SMARTPHONES EXERT REVERSIBLE EFFECTS ON STRATA PROGRAMMABLE VALVES WITHOUT PRODUCING REMARKABLE RADIOLOGIC FINDINGS AND IRREVERSIBLE EFFECTS ON CODMAN CERTAS VALVES.¿ 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
    433658 CODMAN CERTAS VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1