BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPOINT STEREOTACTIC PLATFORM

    MDR report key: 12821534 · Received November 16, 2021

    Report

    Report Number
    3002250546-2021-00004
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 15, 2021
    Manufacturer
    FHC
    Product Code
    HAW
    UDI-DI
    00873263005903
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HIGHLY PROBABLE ROOT CAUSE: (USER ERROR) THE LEAD SLIPPED IN THE DEPTH STOP BECAUSE THE DEPTH STOP WAS NOT TIGHTENED WHEN THE LEAD WAS INSERTED THE SECOND TIME.

    Description of Event or Problem · 0

    AFTER DBS BILATERAL LEAD PLACEMENT SURGERY USING STARFIX BILATERAL PLATFORM, IT WAS NOTED THAT THE POST OP CT REVEALED THAT ON THE LEFT SIDE THE LEAD WAS PLACED APPROPRIATELY, HOWEVER THE RIGHT SIDE REVEALED IN POST OP SCANS THAT THE LEAD WAS 2.8 CM DEEPER THAN EXPECTED. THIS DID NOT CAUSE A DELAY IN DBS SURGERY, WHEN THE LEAD WAS PLACED. NO HARM TO THE PATIENT WAS CAUSED DURING THE SURGERY. A REVISION SURGERY WAS COMPLETED THE FOLLOWING DAY AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722353 WAYPOINT STEREOTACTIC PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW FHC MP-KIT-P-BI 00873263005903

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization