BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/4MM, 60 CM

    MDR report key: 18631480 · Received February 2, 2024

    Report

    Report Number
    1627487-2024-00600
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 2, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406048
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: SCS OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: , BATCH: 3951715 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

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN FULL SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD IS A FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535393 QUATTRODE LEAD, 3/4MM, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3146 3795848 05414734406048

    Patients

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