BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 16820432 · Received April 26, 2023

    Report

    Report Number
    1627487-2023-01961
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    April 6, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE 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 OCTRODE PERCUTANEOUS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8031753.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD CAUSED THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080876 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 8031753 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other SCS ANCHORS (X2)| SCS IPG| SCS LEAD