BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 21527484 · Received March 5, 2025

    Report

    Report Number
    3006705815-2025-01471
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 5, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    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

    DATE OF EVENT IS ESTIMATED. 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. THE ALLEGATION IS AGAINST 1 OF 2 ANCHORS; HOWEVER, IT IS UNKNOWN WHICH ANCHOR, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS ANCHOR, MODEL: 1192, UDI: (B)(4) , BATCH: 9110821.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCING PAIN AT THE IPG SITE ALONG WITH DIFFICULTY REMEMBERING TO CHARGE THE IPG. DIAGNOSTIC TESTING REVEALED BOTH LEADS HAD MIGRATED AND THE LEFT ANCHOR HAD SNAPPED INTO TWO PIECES. AS RESULT, THE SYSTEM WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY. IT IS UNKNOWN WHICH ANCHOR CONTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480911 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000144900 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR