BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 16710673 · Received April 10, 2023

    Report

    Report Number
    1627487-2023-01588
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    January 10, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406130
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCED LEAD MIGRATION/ RECHARGE BURDEN WAS REPORTED TO ABBOTT. IT WAS DETERMINED THE IPG WAS ELECTIVELY REPLACED AS THE IPG EXCEEDED EXPECTED LONGEVITY AND PATIENT CONTINUED TO HAVE THERAPY. THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS LEAD MIGRATION. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF TWO LEADS; HOWEVER, IT IS UNKNOWN WHICH, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE LEAD KIT, 60CM LENGTH, MODEL: 3186ANS, UDI: (10)3333114(17)130328, SERIAL: N/A, BATCH: 3333114.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE EXISTING LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398248 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 3547075 05414734406130

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHOR X2| SCS IPG X1