BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 18141372 · Received November 15, 2023

    Report

    Report Number
    1627487-2023-05453
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406116
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: QUATTRODE LEAD WIDE SPACED, 90 CM, MODEL: 3169, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5946183 COMMON DEVICE NAME: QUATTRODE LEAD WIDE SPACED, 60 CM, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5836569 COMMON DEVICE NAME: QUATTRODE LEAD WIDE SPACED, 60 CM MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5836569

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. IN TURN, REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320871 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD LGW ABBOTT MEDICAL 3169 5946183 05414734406116

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Other LEAD EXTENSION (2)| SCS IPG