BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATAMR VALVE/SHUNT

    MDR report key: 14252874 · Received April 29, 2022

    Report

    Report Number
    9612501-2022-00698
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    November 17, 2021
    Report Date
    April 29, 2022
    Manufacturer
    COVIDIEN LLC
    Product Code
    JXG
    PMA / PMN Number
    K152700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    UCISIK, F.E, SIMONETTA, A.B, BONFANTE-MEJIA, E.M. MAGNETIC RESONANCE IMAGING¿RELATED PROGRAMMABLE VENTRICULOPERITONEAL SHUNT VALVE SETTING CHANGES OCCUR OFTEN. ACTA NEUROCHIRURGICA. 2022. (164) 495-498 HTTPS://DOI.ORG/10.1007/S00701-021-05060-2. PURPOSE: PATIENTS WITH PROGRAMMABLE VENTRICULOPERITONEAL (VP) SHUNT VALVES UNDERGO MULTIPLE SKULL RADIOGRAPHS TO EVALUATE FOR SETTING CHANGES RESULTING FROM MRI. OUR PURPOSE WAS TO DETERMINE THE RATES OF INADVERTENT, MRI-RELATED, PROGRAMMABLE VP SHUNT VALVE SETTING CHANGES. MATERIALS AND METHODS: IN THIS RETROSPECTIVE COHORT WITH A STUDY PERIOD OF JANUARY 2015¿DECEMBER 2018, WE REVIEWED THE PRE- AND POST-MRI SKULL RADIOGRAPHS OF PATIENTS WITH PROGRAMMABLE VP SHUNTS AND COLLECTED THE FOLLOWING DATA: DEMOGRAPHICS, COMMERCIAL TYPE OF THE VALVE USED, MAGNETIC FIELD STRENGTH OF THE MRI DEVICE USED, AND WHETHER A SETTING CHANGE OCCURRED. WE USED THE CHI-SQUARE TEST TO IDENTIFY VARIABLES ASSOCIATED WITH VALVE SETTING CHANGE. RESULTS: WE IDENTIFIED 210 MRI EXPOSURE EVENTS IN 156 PATIENTS, AND AN MRI-RELATED VALVE SETTING CHANGE RATE OF 56.7%. THE SETTING CHANGE RATE WAS SIGNIFICANTLY HIGHER WITH HIGHER MAGNETIC FLED STRENGTH (P=0.03), AND WITH MEDTRONIC STRATA¿ VALVES COMPARED TO CODMAN HAKIM¿ VALVES (P<(> <<)>0.0001). CONCLUSION: INADVERTENT, MRI-RELATED SHUNT VALVE SETTING CHANGES ARE FREQUENT WITH VALVES THAT LACK A LOCKING MECHANISM. THEREFORE, WE SUGGEST THAT WHEN FEASIBLE, THE CLINICIANS COULD OPT TO MANUALLY REPROGRAM THE VALVES AFTER THE MRI TO THE PREFERRED SETTING WITHOUT THE NEED FOR PRE- AND POST-MRI RADIOGRAPHS. WE BELIEVE THAT THIS PROTOCOL MODIFICATION COULD HELP REDUCE IONIZING RADIATION EXPOSURE AND COST. MANUFACTURERS MAY CONSIDER INCORPORATING LOCKING MECHANISMS INTO THE DESIGN OF SUCH DEVICES IN ORDER TO REDUCE THE UNINTENDED SETTING CHANGE RATES. REPORTABLE EVENTS: MEDTRONIC STRATA II¿ VALVES UNDERWENT SETTING CHANGES 87% OF THE TIME MEDTRONIC STRATA NSC¿ 85.2% OF THE TIME THE SETTINGS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98922 UNKNOWN STRATAMR VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG COVIDIEN LLC UNKNOWN-SMR

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male