BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3954915 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-01465
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 IPG IS INOPERABLE DUE TO LACK OF RECHARGE FOR THE PAST TWO MONTHS. SUBSEQUENTLY, COMMUNICATION CEASED BETWEEN THE EXTERNAL DEVICES AND THE IPG. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 EXPLANTING AND REPLACING THE IPG. EFFECTIVE COVERAGE WAS ACHIEVED POSTOPERATIVELY. THE TISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416313 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2839905

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)