BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 2861090 · Received December 4, 2012

    Report

    Report Number
    1627487-2012-12700
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    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 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

    IT WAS REPORTED THE PT EXPERIENCED PAIN AND INFLAMMATION AT THE ANCHOR SITE. REPORTEDLY THE PT HAS AN APPOINTMENT WITH THE IMPLANTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 3702048

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788