BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 12668585 · Received October 20, 2021

    Report

    Report Number
    3006705815-2021-05184
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    October 7, 2021
    Report Date
    February 14, 2022
    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
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED DEVICE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REVEALED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SYSTEM WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBERS 3006705815-2021-05185, 1627487-2021-17825, 1627487-2021-17826. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE LEAD INSERTION SITE. IT IS CURRENTLY UNKNOWN WHAT INTERVENTION WILL BE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563722 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000108988 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other 1192, SCS ANCHOR (2)| 3186, SCS LEAD