BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 3022344 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-03413
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT RECEIVED 2 SCS ANCHORS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PT IS EXPERIENCING PAIN AT HER SCS ANCHOR SITES. THE PHYSICIAN BELIEVES THE ANCHORS NEED TO BE BURIED DEEPER INTO THE FACIA AND SEPARATED. SUBSEQUENTLY, SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120602 ANCHOR SCS ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3742238

    Patients

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