BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 4223274 · Received October 29, 2014

    Report

    Report Number
    1627487-2014-21690
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    January 20, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PATIENT LOST WEIGHT AND EXPERIENCES PAIN AT THE ANCHOR SITE DUE TO BULGING OF THE ANCHORS. SUBSEQUENTLY, SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT THE ANCHORS. IT WAS REPORTED REMOVING THE ANCHORS HAS PROVIDED RELIEF TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691227 SWIFT LOCK ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other SCS LEAD, MODEL: 3186(2),| IMPLANT DATE:| SCS IPG, MODEL: 3788,| IMPLANT DATE: