BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 19966951 · Received August 12, 2024

    Report

    Report Number
    1627487-2024-10371
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Removal / Correction Number
    0296004345
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTER PHONE NUMBER. B3-DATE OF EVENT IS ESTIMATED. IT WAS REPORTED TO ABBOTT, A PATIENT UNDERWENT A REVISION WHERE THE LEADS AND IPG WERE EXPLANTED AND REPLACED. THERE WERE HIGH IMPEDANCES ON ONE LEAD AND THE IPG WAS 4.5 YEARS OLD. THERE WERE NO COMPLICATIONS. EFFECTIVE THERAPY WAS RESTORED. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5 - DESCRIBE EVENT OR PROBLEM. H11 - ADDITIONAL NARRATIVE/DATA. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), LOT: 7133328.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS ASSOCIATED WITH THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200917 OCTRODE LEAD KIT, 60CM LENGTH STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL 3186 7411490 05415067017246

    Patients

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