BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH ELECTRODE

    MDR report key: 14316756 · Received May 7, 2022

    Report

    Report Number
    2183456-2022-00012
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    August 29, 2019
    Report Date
    May 6, 2022
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K163355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE INITIAL ASSESSMENT OF THIS COMPLAINT, IT WAS DETERMINED THAT THIS WAS NOT A REPORTABLE EVENT AS THERE WAS NO PATIENT IMPACT AND THE RISK OF PATIENT HARM WAS THOUGHT TO BE REMOTE AT THE TIME. HOWEVER, DURING THE 2022 FDA INSPECTION, IT WAS SUGGESTED AD-TECH RE-EVALUATE THE REPORTABILITY FOR THIS COMPLAINT. FDA ADVISED AD-TECH THAT AS LATER COMPLAINTS FOR "BENT ELECTRODE" WERE CONSIDERED REPORTABLE DUE TO RISK FILE INTERPRETATION BASED ON CLINICIAN INPUT, EARLIER COMPLAINTS SHOULD HAVE ALSO BE REPORTED. THEREFORE, MDR 2183456-2022-00011 HAS BEEN FILED PAST THE 30-DAY TIMEFRAME. AS DOCUMENTED WITHIN THE COMPLAINT, THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS ISSUE. PER OUR RISK ASSESSMENT, THE RISK REMAINS ALAP (AS LOW AS POSSIBLE) AND MATCHES THAT OF THE RISK FILE. NO UPDATES TO THE RISK FILE ARE NEEDED AT THIS TIME. THE BENT ELECTRODES WERE NOT RETURNED TO AD-TECH, THEREFORE, NO FURTHER EVALUATION COULD BE PERFORMED. THE CAUSE WAS DEEMED INCONCLUSIVE AS VERY LITTLE INFORMATION WAS OBTAINED FROM THE COMPLAINANT. THIS COMPLAINT WAS CLOSED AND THE TREND CODE IS BEING MONITORED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    ON (B)(6) 2019, AD-TECH WAS INFORMED THAT DEPTH ELECTRODES WERE UNABLE TO BE USED DUE TO BENT STYLETS. THE ALLEGED DEFICIENCY WAS FOUND BEFORE IMPLANTATION AND OTHER ELECTRODES WERE USED. THERE WAS NO IMPACT TO THE PATIENT. NO PRODUCT WAS RETURNED FOR ANALYSIS AND NO LOT INFORMATION WAS PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078030 DEPTH ELECTRODE SPENCER DEPTH ELECTRODE GZL AD-TECH MEDICAL INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown