BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 17107598 · Received June 12, 2023

    Report

    Report Number
    1627487-2023-02784
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF THE EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080439. A PATIENT EXPERIENCING LEAD MIGRATION WAS REPORTED TO ABBOTT. THE PATIENT¿S LEAD WAS REVISED. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S RIGHT OCCIPITAL LEAD HAD MIGRATED. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH OCCIPITAL LEAD HAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276129 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 8080439 05414734401661

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other SCS EXTENSION (2)| SCS IPG| SCS LEAD (3)