BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 20728489 · Received November 19, 2024

    Report

    Report Number
    1627487-2024-12106
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 5, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401708
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186ANS, UDI: (B)(4), SERIAL: N/A, BATCH: 3153760. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. A LEAD DIAGNOSIS WAS PERFORMED AND REVEALED HIGH IMPEDANCES ACROSS THE LEAD. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL IN RESTORING EFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNDETERMINED WHICH LEAD HAD HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008478 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 3153760 05414734401708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS ANCHOR (2X).| SCS IPG.| SCS LEAD.