BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 8650610 · Received May 29, 2019

    Report

    Report Number
    1627487-2019-06239
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER 1627487-2019-062380. IT WAS REPORTED BOTH OF THE PATIENT'S LEADS MIGRATED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443216 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 6209189 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other MODEL: 3186, SCS LEAD