BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 14342486 · Received May 9, 2022

    Report

    Report Number
    1627487-2022-02614
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 9, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406130
    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. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION 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:1627487-2022-102615. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED NERVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789543 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 4703166 05414734406130

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS ANCHOR (X2)| SCS IPG