BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/4MM, 60 CM

    MDR report key: 17303169 · Received July 11, 2023

    Report

    Report Number
    1627487-2023-03278
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 14, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3286, UDI: (B)(4), SERIAL: N/A, BATCH: 3450399. COMMON DEVICE NAME: SCS LEAD, MODEL: 3146, UDI: (B)(4), SERIAL: N/A, BATCH: 3110796.

    Description of Event or Problem · 0

    DURING THE IPG REPLACEMENT PROCEDURE, WHEN PHYSICIAN WAS EXPLANTED THE IPG, THE PHYSICIAN CUT ONE OF THE LEADS. AS SUCH, A LEAD WAS ADDED. THE PHYSICIAN DID NOT REMOVE THE LEAD THAT WAS CUT. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD THE PHYSICIAN CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233141 QUATTRODE LEAD, 3/4MM, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3146 3110057 05414734401586

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS ANCHORS (2)| SCS EXTENSION| SCS IPG| SCS LEAD (2)