BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPENCER DEPTH ELECTRODES

    MDR report key: 14187234 · Received April 22, 2022

    Report

    Report Number
    2183456-2022-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 22, 2022
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K163355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    13 DEPTH ELECTRODES WERE INVOLVED IN THE CASE. RETURN INSPECTION CONFIRMED SIGNAL LOSS ON SOME OR ALL CONTACTS OF EACH ELECTRODE. QUANTITY, CATALOG #, UDI, MFG. DATE 2, SD06R-SP10X-000, (B)(4), 01/04/2022; 1, SD08R-SP05X-000, (B)(4), 01/28/2022; 1, SD08R-SP05X-000, (B)(4), 12/04/2021; 1, SD10R-SP05X-000, (B)(4), 12/16/2021; 5, SD10R-SP05X-000, (B)(4), 02/18/2022; 1, SD12R-SP05X-000, (B)(4), 01/05/2022; 1, SD14R-SP05X-000, (B)(4), 12/06/2021; 1, SD14R-SP05X-000, (B)(4), 01/12/2022. 2 SUBDURAL ELECTRODES WERE ALSO INVOLVED IN THE CASE. REPORTED UNDER MDR 2183456-2022-00008.

    Description of Event or Problem · 0

    MULTIPLE ELECTRODES PRESENTED WITH ARTIFACT DESPITE TROUBLESHOOTING WITH NEW HEADBOX. ANOTHER DIAGNOSTIC PROCEDURE WILL NEED TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273429 SPENCER DEPTH ELECTRODES DEPTH ELECTRODE GZL AD-TECH MEDICAL INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown