BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3162397 · Received June 6, 2013

    Report

    Report Number
    1627487-2013-05793
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT #: 1627487-2013-05792. IT WAS REPORTED THE PATIENT HAS TO RECHARGE THE IPG FREQUENTLY. LONGEVITY CALCULATIONS REVEALED THE PATIENT SHOULD NOT HAVE TO RECHARGE AS OFTEN AS HE HAS BEEN. THE PATIENT HAS TWO IPGS. IT IS UNKNOWN WHICH IPG THE PATIENT IS HAVING ISSUES WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250056 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3931466

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention IMPLANT:| IMPLANT:| IMPLANT:| SCS ANCHORS, MODEL: 1192 (X2)| SCS EXTENSION: MODEL 3386| SCS EXTENSIONS: MODEL: 3386 (X2)| SCS LEADS, MODEL: 3186 (X2)| IMPLANT:| SCS LEADS, MODEL: 3186 (X2)| IMPLANT: