BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD KIT, 60CM LENGTH

    MDR report key: 17737685 · Received September 13, 2023

    Report

    Report Number
    1627487-2023-04355
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    May 31, 2019
    Report Date
    September 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3183, UDI: (B)(4), SERIAL: N/A, BATCH: 3870884.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DURAL TEAR DURING THE EXPLANT OF HER SYSTEM ON (B)(6) 2023, RESULTING IN HEADACHES, NAUSEA, AND VOMITING. AN UNSPECIFIED STEROID AND INTRAVENOUS FLUIDS WERE ADMINISTERED TO THE PATIENT, AND A BLOOD PATCH WAS PERFORMED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109073 LAMITRODE 44 LEAD KIT, 60CM LENGTH STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL 3244 3491200

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS IPG (X1)| SCS LEAD (X1)