BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 20587468 · Received November 1, 2024

    Report

    Report Number
    1627487-2024-11748
    Event Type
    Injury
    Date Received
    November 1, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. DATE OF EVENT / DATE OF EXPLANT WERE REQUESTED BUT NOT RECEIVED. 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: OCTRODE LEAD KIT, 60CM LENGTH, MODEL: 3186, UDI: (B)(4), BATCH: 3153204.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER MULTIPLE FALLS. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED VIA SURGICAL INTERVENTION. IT IS UNKNOWN WHICH LEAD CAUSED / CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167328 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 3153204

    Patients

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