BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT-LOCK ANCHOR

    MDR report key: 18628473 · Received February 1, 2024

    Report

    Report Number
    1627487-2024-00592
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 3, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    UDI-DI
    05415067024084
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 1192, UDI: (B)(4), BATCH: 8874960.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCED PAIN AT THE ANCHOR SIDE WAS REPORTED TO ABBOTT. IT WAS DETERMINED THAT DURING A SURGICAL INTERVENTION PROCEDURE, A FLUID DISCHARGE WAS NOTICED AT THE IPG POCKET AND INCISION SIDES. AS A RESULT, THE PHYSICIAN OPTED TO EXPLANT THE ENTIRE SYSTEM TO ADDRESS THE ISSUE. AS A RESULT, A DEVICE HISTORY RECORD WAS PERFORMED TO REVIEW AND CONFIRM THE STERILITY OF DEVICES. BASED ON THE DOCUMENTS REVIEWED, THE SOURCE OF THE INFECTION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCING PAIN AT THE ANCHOR SITE WAS REPORTED TO ABBOTT. THE PATIENT SYSTEM WAS EXPLANTED. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER (B)(4). RELATED MANUFACTURER REFERENCE NUMBER (B)(4). RELATED MANUFACTURER REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE ANCHOR SIDE. DURING A SURGICAL INTERVENTION PROCEDURE, A FLUID DISCHARGE WAS NOTICED AT THE IPG POCKET AND INCISION SIDES. AS A RESULT, THE PHYSICIAN OPTED TO EXPLANT THE ENTIRE SYSTEM TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ANCHOR THAT WAS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249325 SWIFT-LOCK ANCHOR SCS ANCHOR GZB ABBOTT MEDICAL 1192 8874960 05415067024084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR