BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 21845063 · Received April 15, 2025

    Report

    Report Number
    3006705815-2025-02682
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 15, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    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

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), LOT: A000158007. A PATIENT EXPERIENCING LEAD MIGRATION WAS REPORTED TO ABBOTT. THE PATIENT¿S LEAD WAS REPLACED. THERAPY WAS RESTORED. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IPG REPLACEMENT ON (B)(6) 2025, (RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2025-002990, THE PHYSICIAN NOTICED THAT BOTH LEADS HAD MIGRATED. ATTEMPTS TO PLACE A NEW LEAD AND MOVE THE NEW LEAD TO T10 WERE UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN OPTED TO EXPLANT AND REPLACE ONE LEAD. NO INTERVENTION WAS DONE WITH THE SECOND LEAD. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2378727 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000157949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR X2| SCS LEAD