BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 18222532 · Received November 28, 2023

    Report

    Report Number
    1627487-2023-05641
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 22, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF THE EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080439. COMMON DEVICE NAME: SCS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080439. COMMON DEVICE NAME: SCS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8080439.

    Additional Manufacturer Narrative · 0

    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 THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD RESULTED IN INEFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602371 QUATTRODE LEAD WIDE SPACED, 60 CM DRG LEAD LGW ABBOTT MEDICAL 3166 8080439 05414734401661

    Patients

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