BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 21194227 · Received January 20, 2025

    Report

    Report Number
    1627487-2025-00277
    Event Type
    Injury
    Date Received
    January 20, 2025
    Date of Event
    January 31, 2024
    Report Date
    February 18, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401661
    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 QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080438. COMMON DEVICE NAME: SCS QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080438 COMMON DEVICE NAME: SCS QUATTRODE LEAD, MODEL: 3166, UDI: (B)(6), SERIAL: (B)(6), BATCH: 8080438.

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN IN 2021 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD ATTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555535 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 8080438 05414734401661

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other EXTENSION (2)| SCS IPG| SCS LEAD (3)