BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA BRAIN

    MDR report key: 8685870 · Received June 11, 2019

    Report

    Report Number
    3009185973-2019-00187
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 13, 2019
    Report Date
    January 28, 2020
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K172444
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT POST-OPERATIVE SCAN SHOWED THAT ELECTRODES WERE IMPLANTED INACCURATELY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE INACCURACY IS CONFIRMED FOR THE 21 ELECTRODES. THE MOST PROBABLE ROOT CAUSES OF THIS EVENT ARE: - THE IMAGE FUSION QUALITY OF PRE AND POST-OPERATIVE FUSIONS : THE IMAGES WERE MERGED AUTOMATICALLY AND THAT NO MANUAL ADJUSTMENTS WERE MADE BY THE USER. - AN UNDETECTED HEAD SHIFT AFTER THE REGISTRATION - THE REGISTRATION METHOD AND ITS QUALITY : THE QUALITY OF THE REGISTRATION ON THE SIDES AND THE BACK OF THE SKULL CANNOT BE DETERMINED, AS NO EXTRA POINT WAS TAKEN ON THOSE AREAS. NONE OF THESE HYPOTHESES COULD BE CONFIRMED WITH AVAILABLE INFORMATION; THE ROOT CAUSE FOR THE INACCURACY CANNOT BE DETERMINED. THE SURGEON WAS TRAINED ON THE DEVICE.

    Description of Event or Problem · 0

    AFTER SEEG, PATIENT RECEIVED POST-OP CT AND MR. UPON MERGE WITH PRE-OPERATIVE IMAGING, IT WAS REVEALED THAT PLACEMENT OF DEPTH ELECTRODES WAS INACCURATE. THE RIGHT-SIDED LEADS ARE ALL LOW, BUT THE LEFT-SIDED ONES LOOK GOOD. NO SUSPECTED HEAD SHIFT, AND RIGHT SIDE WAS DONE BEFORE LEFT. SURGEON BELIEVES THAT THE IMAGE MERGE WAS CORRECT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT DUE TO THE IMPRECISION.

    Additional Manufacturer Narrative · 1

    UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AFTER SEEG, PATIENT RECEIVED POST-OP CT AND MR. UPON MERGE WITH PRE-OPERATIVE IMAGING, IT WAS REVEALED THAT PLACEMENT OF DEPTH ELECTRODES WAS INACCURATE. THE RIGHT-SIDED LEADS ARE ALL LOW, BUT THE LEFT-SIDED ONES LOOK GOOD. NO SUSPECTED HEAD SHIFT, AND RIGHT SIDE WAS DONE BEFORE LEFT. SURGEON BELIEVES THAT THE IMAGE MERGE WAS CORRECT. THERE WAS NO ADVERSE EFFECT ON THE PATIENT DUE TO THE IMPRECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482696 ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA BRAIN 3.0.0.21

    Patients

    Seq Age Sex Outcome Treatment
    1