BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 6961690 · Received October 19, 2017

    Report

    Report Number
    2021898-2017-00523
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Report Date
    October 19, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY.

    Description of Event or Problem · 1

    MATTHEW J. PIERSON, DANIEL WEHRMANN, J. ANDREW ALBERS, NAJIB E. EL TECLE, DARY COSTA, SAMER K. ELBABAA. PROGRAMMABLE SHUNT VALVE INT ERACTIONS WITH OSSEOINTEGRATED HEARING DEVICES. JOURNAL OF NEUROSURGERY PEDIATRICS 19 (2017). DOI: 10.3171/2016.11.PEDS16501 OBJECTIVE PATIENTS WITH VENTRICULOPERITONEAL (VP) SHUNTS WITH PROGRAMMABLE VALVES WHO WOULD BENEFIT FROM OSSEOINTEGRATED HEARING DEV ICES (OIHDS) REPRESENT A UNIQUE POPULATION. THE AIM OF THIS STUDY WAS TO EVALUATE THE MAGNETIC FIELD STRENGTHS OF 4 OIHDS AND THEIR INTERACTIONS WITH 5 PROGRAMMABLE VP SHUNT VALVES. METHODS MAGNETIC FIELD STRENGTH WAS MEASURED AS A FUNCTION OF DISTANCE FOR EACH HEARING DEVICE (COCHLEAR BAHA 5, COCHLEAR BAHA BP110, OTICON PONTO PLUS POWER, AND MEDTRONIC SOPHONO) IN THE FOLLOWING MODES: INACTIVE, ACTIVE IN QUIET, AND ACTIVE IN 60 DECIBELS OF BACKGROUND NOISE IN THE SOUND BOOTH. THE HEARING DEVICES WERE INTRODUCED TO EACH SHUNT VALVE (AESCULAP PROGAV, AESCULAP PROGAV 2.0, CODMAN HAKIM, CODMAN CERTAS, AND MEDTRONIC STRATA II) ALSO AS A FUNCTION OF DISTANCE IN THESE IDENTICAL 3 SETTINGS. EACH TRIAL WAS REPEATED 5 TIMES. BETWEEN EACH TRIAL, THE VALVES WERE ASSESSED FOR A CHANGE IN SETTING. FINALLY, USING A SKULL MODEL, THE DEVICES WERE INTRODUCED TO EACH OTHER IN STANDARD ANATOMICAL LOCATIONS AND THE VALVES WERE ASSESSED FOR A CHANGE IN SETTINGS. RESULTS THE MAXIMUM MAGNETIC FIELD STRENGTHS GENERATED BY THE COCHLEAR BAHA 5, BP110, AND OTICON OIH DS WERE 1.1, 36.2, AND 48.7 GAUSS (G), RESPECTIVELY. THE MAXIMUM STRENGTH GENERATED BY THE SOPHONO DEVICE WAS > 800 G. THE MAGNETIC FIELD STRENGTH OF THE HEARING DEVICES DECREASED MARKEDLY WITH INCREASING DISTANCE FROM THE DEVICE. THE STRENGTH OF THE SOPHONO¿S MAGNETIC ATTACHMENT DECREASED TO 34.8 G AT 5 MM. THE CODMAN HAKIM, CODMAN CERTAS, AND MEDTRONIC STRATA II VALVE SETTINGS CHANGED WHEN ROTATING THE VALVES NEXT TO THE SOPHONO ABUTMENT. NO OTHER CHANGES IN VALVE SETTINGS OCCURRED IN THE DISTANCE OR ANATOMICAL MODELS FOR ANY OTHER TRIALS. CONCLUSIONS THIS IS THE FIRST STUDY EVALUATING THE INTERACTION BETWEEN OIHDS AND PROGRAMMABLE VP SHUNT VALVES. THE FINDINGS SUGGEST THAT IT IS SAFE TO USE THESE DEVICES TOGETHER WITHOUT HAVING TO SWITCH TO A NONPROGRAMMABLE VALVE OR MOVE THE SHUNT VALVE TO A MORE DISTANT LOCATION. STILL, CARE SHOULD BE TAKEN IF THE SOPHONO DEVICE IS USED TO ENSURE THAT THE VALVE IS = 5 MM AWAY FROM THE MAGNETIC ATTACHMENT. REPORTED EVENT: IT WAS REPORTED THAT THE MEDTRONIC STRATA II VALVE WAS REPROGRAMMED WHEN ROTATED IN CONTACT WITH THE MEDTRONIC SOPHONO HEARING AND ABUTMENT SCREW. SEE ATTACHED JOURNAL ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740550 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1