BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 19262132 · Received May 7, 2024

    Report

    Report Number
    1627487-2024-08580
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    March 7, 2024
    Report Date
    July 1, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 -DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI (B)(4), SERIAL: (B)(6), BATCH: 7252281.

    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 ONE OF THE PATIENT'S LEADS HAD MIGRATED DOWN TO THE IPG POCKET SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 DURING WHICH THE MIGRATED LEAD WAS EXPLANTED AND REPLACED. THEREBY RESTORING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668854 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 7110413 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR X 2| SCS LEAD