BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 19978504 · Received August 13, 2024

    Report

    Report Number
    1627487-2024-10403
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 8, 2024
    Report Date
    March 3, 2025
    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

    A PATIENT EXPERIENCING AUTOREDUCING DUE TO A LEAD FRACTURE WAS REPORTED TO ABBOTT. NO INTERVENTION IS PLANNED AT THIS TIME. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCING AUTOREDUCING DUE TO A LEAD FRACTURE WAS REPORTED TO ABBOTT. THE PATIENT¿S LEAD WAS REPLACED. THERAPY WAS RESTORED. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), LOT: 7110366

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN, THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER A MAMMOGRAM. IMAGING SHOWED THAT THE LEFT OCCIPITAL LEAD WAS FRACTURED DURING MAMMOGRAM. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT WAS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263261 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 7110366 05414734406109

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other SCS EXTENSION X2| SCS IPG| SCS LEAD X3