BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING ELECTRODES

    MDR report key: 1825971 · Received August 31, 2010

    Report

    Report Number
    3005677147-2010-00007
    Event Type
    Other
    Date Received
    August 31, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A WRONG PRODUCT USED ERROR. THE USER INADVERTENTLY USED THE WRONG LENGTH ELECTRODE. THE PT SHOWED NO NEGATIVE SIDE EFFECT AT THE TIME OF SURGERY. ELECTRODE USED WAS FOR A FRAME BASED SURGERY WHEN THE SURGEON WAS TO HAVE USED PLATFORM BASED ELECTRODES AS THIS WAS A PLATFORM BASED SURGERY. THE ELECTRODE WAS REMOVED, THE DBS LEAD WAS INSERTED AT TARGET AND THE SECOND SIDE WAS SCHEDULED FOR THE WEEK OF (B)(6) 2010.

    Description of Event or Problem · 1

    FHC (B)(6) OFFICE REPORTED TO FHC TECHNICAL SERVICES THAT THE WRONG LENGTH MICROELECTRODE WAS USED DURING A SURGERY. THE PT SHOWED NO NEGATIVE SIDE EFFECT AT THE TIME OF SURGERY. THIS WAS A BILATERAL SURGERY: ONE DBS LEAD WAS IMPLANTED SUCCESSFULLY; THE OTHER SIDE WAS SCHEDULED DUE TO THE LENGTH OF TIME OF THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODES ELECTRODES GZL FHC, INC. 479321

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MICROTARGETING STAR DRIVE SYSTEM