BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 30 CM

    MDR report key: 22553741 · Received July 21, 2025

    Report

    Report Number
    1627487-2025-03596
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: QUATTRODE, MODEL: 3166, UDI: (B)(4), SERIAL: NA, BATCH: 2812296. COMMON DEVICE NAME: OCTRODE, MODEL: 3186, UDI: (B)(4), SERIAL: NA, BATCH: 2822545. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037359 QUATTRODE LEAD WIDE SPACED, 30 CM SCS LEAD LGW ABBOTT MEDICAL 3163 175091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS EXTENSION| SCS IPG| SCS LEADX2