BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 3161435 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-15773
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAS SWELLING AROUND HER ANCHOR SITE WHICH IS CAUSING DISCOMFORT. THE PATIENT STATED HER INCISIONS HAVE HEALED, BUT THE ANCHOR SITE REMAINS SWOLLEN AND HARD. THE PATIENT WAS ADVISED TO CONSULT WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248923 SWIFT LOCK ANCHOR SCS ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3530198

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| SCS LEAD, MODEL 3186 (2)| IMPLANT DATE: