BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISEON MINI

    MDR report key: 3925880 · Received June 13, 2014

    Report

    Report Number
    1627487-2014-23397
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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 PT'S IPG SITE IS SENSITIVE AND IRRITATED. IT WAS ALSO REPORTED THE PT IS NOT USING THE SYSTEM BECAUSE SHE NO LONGER HAS THE ORIGINAL PAIN. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349300 ISEON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3520147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT DATE:| SCS ANCHOR: MODEL 1194| MPLANT DATE:| SCS LEAD: MODEL 3228