BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192040 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-08231
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PATIENT'S PHYSICIAN IMPLANTED A NEW IPG (IMPLANTABLE PULSE GENERATOR) AND CONNECTED THE EXISTING THORACIC LEAD FROM THE EXISTING IPG TO THE NEW IPG. THE ORIGINAL IPG REMAINED IMPLANTED. FOLLOW-UP INFORMATION RECEIVED THE REASON FOR THE ADDITION OF THE IPG AS INCREASED RECHARGE BURDEN. IT WAS REPORTED THE PATIENT HAD EFFECTIVE STIMULATION AND WAS RECHARGING EVERY FOUR DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281025 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3359052

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SCS LEAD, MODEL 3186| SCS EXTENSION, MODEL 3383| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192| SCS LEAD, MODEL 3189| IMPLANT DATE:| IMPLANT DATE: