BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 18707651 · Received February 14, 2024

    Report

    Report Number
    1627487-2024-00794
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 14, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    UDI-DI
    05415067024084
    PMA / PMN Number
    K092371
    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. THE ALLEGATION IS AGAINST 1 OF 2 ANCHORS; HOWEVER, IT IS UNKNOWN WHICH ANCHOR, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS SWIFT LOCK ANCHOR, MODEL: 1192, UDI:(B)(4), SERIAL: N/A, BATCH: 9110830. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE ANCHOR SITE BECAUSE THE ANCHOR WAS SUPERFICIAL DUE TO THE PATIENT'S ANATOMY. THE PATIENT IS LEAN, AND THE ANCHOR COULD NOT SIT DEEP IN ENOUGH IN THE PATIENT'S TISSUE TO BE COMFORTABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE PATIENT'S ANCHOR WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH ANCHOR IS LIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240547 SWIFT-LOCK ANCHOR Stimulator, spinal-cord, implanted (pain relief) GZB ABBOTT MEDICAL 1192 9110830 05415067024084

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other SCS ANCHOR| SCS IPG| SCS LEAD (2)