BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 17339405 · Received July 17, 2023

    Report

    Report Number
    1627487-2023-03371
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    June 14, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406109
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), LOT: 7110355. 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.

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT THE LEFT OCCIPITAL LEAD HAD FRACTURED AND PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHEREIN, ANOTHER LEAD WAS ADDED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD HAD FRACTURED.

    Description of Event or Problem · 0

    IT REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ON THE LEFT OCCIPITAL LEAD. PATIENT IS RECEIVING EFFECTIVE THERAPY, HOWEVER, MAY REQUIRE SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142449 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 7110355 05414734406109

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other SCS EXTENSION X2| SCS IPG| SCS LEAD X3