BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AD-TECH DEPTH ELECTRODE

    MDR report key: 12642761 · Received October 15, 2021

    Report

    Report Number
    2183456-2021-00011
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 14, 2021
    Report Date
    June 13, 2022
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K163355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED 6/13/2022. NO FURTHER INFORMATION WAS RECEIVED FOR THIS COMPLAINT AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION THE ROOT CAUSE WAS DEEMED INCONCLUSIVE. PER THE RISK ASSESSMENT, THE CALCULATED OCCURRENCE MATCHES THE OCCURRENCE LEVEL PRESENT IN THE RISK FILE AND THE RESULTING RISK LEVEL WILL REMAIN "ACCEPTABLE". NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    A HEMORRHAGE OCCURED DURING ELECTRODE EXPLANT PROCEDURE. THE PATIENT WAS INTUBATED AND AN INTRAVENTRICULAR DRAIN WAS PLACED. PATIENT WAS EXTUBATED LATER THAT DAY AND WAS REPORTED AS "SEEMS TO BE DOING OKAY".

    Description of Event or Problem · 1

    A HEMORRHAGE OCCURED DURING ELECTRODE EXPLANT PROCEDURE. THE PATIENT WAS INTUBATED AND AN INTRAVENTRICULAR DRAIN WAS PLACED. PATIENT WAS EXTUBATED LATER THAT DAY AND WAS REPORTED AS "SEEMS TO BE DOING OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536150 AD-TECH DEPTH ELECTRODE DEPTH ELECTRODE GZL AD-TECH MEDICAL INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention