BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3810480 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-25349
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBERS: 1627487-12192011-003-R, 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. 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

    THE PATIENT REPORTED EXPERIENCING BURNING AND SORENESS AT THE IPG SITE REGARDLESS OF STIMULATION OR CHARGING. ADDITIONALLY, THE PATIENT REPORTED THAT AFTER SHE GAINED WEIGHT THE IPG SEEMS TO BE PROTRUDING EVENT MORE. X-RAYS REVEALED NO ANOMALIES. THE PATIENT WILL CONSULT HER PHYSICIAN FOR A POSSIBLE REVISION TO MOVE THE POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271823 EON MINI SCS IPG GZB ST. JUDE MEDICAL- NEUROMODULATION 3788 2872732

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHORS: