BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 16570404 · Received March 19, 2023

    Report

    Report Number
    1627487-2023-01190
    Event Type
    Injury
    Date Received
    March 19, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 19, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406109
    PMA / PMN Number
    K072462
    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. THE ALLEGATION IS AGAINST 2 OF 4 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(4), BATCH: 5241620. COMMON DEVICE NAME: SCS QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(4), BATCH: 5241620. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01191. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND DISCOMFORT AT OCCIPITAL LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939356 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 5241620 05414734406109

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other SCS EXTENSION (2)| SCS IPG (1)| SCS LEAD (2)