BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 3110756 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-03620
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K081208
    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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-03619. THE PATIENT RECEIVED 2 SCS ANCHORS WITH DIFFERENT LOT NUMBERS. IT WAS REPORTED THE PATIENT IS EXPERIENCING DISCOMFORT DUE TO HER SCS ANCHORS BEING SUPERFICIAL. SUBSEQUENTLY, SURGICAL INTERVENTION WAS SCHEDULED TO ADDRESS THE ISSUE. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION HAS NOT YET TAKEN PLACE DUE TO THE PATIENT BEING SICK THE DAY THE INTERVENTION WAS SUPPOSED TO TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204796 ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL- NEUROMODULATION 1194 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: