BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 19222487 · Received May 1, 2024

    Report

    Report Number
    1627487-2024-08355
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 1, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    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. SECTION A4: PATIENT WEIGHT IS UNKNOWN. THE ALLEGATION IS AGAINST 1 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 LEAD, MODEL: 3166, UDI: (B)(4), BATCH: 4081179 COMMON DEVICE NAME: SCS LEAD, MODEL: 3163, UDI: (B)(4) BATCH: 4328108 COMMON DEVICE NAME: SCS LEAD, MODEL: 3163, UDI: (B)(4) BATCH: 4317009 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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT'S STIMULATOR HAD NOT BEEN PROVIDING PAIN RELIEF. THE PATIENT NOTED THEY HAD SINCE STOPPED CHARGING THE DEVICE AS STIMULATOR WAS NOT PROVIDING RELIEF. AS SUCH THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144109 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD LGW ABBOTT MEDICAL 3166 3788248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS EXTENSION X 2| SCS LEAD X 3