BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 19928505 · Received August 7, 2024

    Report

    Report Number
    1627487-2024-10211
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    UDI-DI
    05415067024084
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    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 ANCHOR, MODEL: 1192ANS, UDI: (B)(4), SERIAL: N/A, BATCH: 8060993.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED, AND THE ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT IS EXPERIENCING MUSCLE SPASMS AT THE IPG SITE AND ANCHOR SITE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNDETERMINED WHICH ANCHOR THE ALLEGATION IS AGAINST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278042 SWIFT-LOCK ANCHOR SCS ANCHOR GZB ABBOTT MEDICAL 1192 8060993 05415067024084

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other SCS LEAD (2X)