BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 18555242 · Received January 22, 2024

    Report

    Report Number
    3006705815-2024-00588
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    September 15, 2020
    Report Date
    January 31, 2024
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: A000091488.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-00628. RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-00630. IT WAS REPORTED THAT THE PATIENT NEVER EXPERIENCED EFFECTIVE THERAPY SHE WANTED. ADDITIONALLY, THE PATIENT EXPERIENCED ZAPPING SENSATION AT THE IPG SITE WITH STIMULATION ON. THE IPG WAS INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUES. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064170 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000091488 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS LEAD.