BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 18029851 · Received October 30, 2023

    Report

    Report Number
    1627487-2023-05130
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    October 3, 2023
    Report Date
    January 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF TWO LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS, MODEL: 3186, UDI: (B)(4), BATCH: 3810730.

    Additional Manufacturer Narrative · 0

    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 IS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850761 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 3780566 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other SCS IPG| SCS LEAD