BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032289 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01349
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBERS 1627487-07262012-002-R AND 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 IS NOT RECEIVING EFFECTIVE STIMULATION. THE PT REPORTS HE CANNOT TURN THE STIMULATION AS HIGH AS HE WANTS IT, BECAUSE IT RUNS HIS IPG BATTERY DOWN TO QUICKLY. PT IS CONSULTING WITH HIS PHYSICIAN REGARDING AN IPG REPLACEMENT. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131208 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 2846379

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: