BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2971005 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-13227
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 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

    CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13226. THE PT HAD TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PT HAD FALLEN OFF A DECK AND LOST STIMULATION COVERAGE. X-RAYS CONFIRMED THE PT'S LEADS HAD MIGRATED. THE PT UNDERWENT A SURGICAL PROCEDURE, THE LEADS WERE EXPLANTED AND REPLACED WITH ONE SURGICAL LEAD AND ONE PERCUTANEOUS LEAD. DURING THE PROCEDURE, THE PHYSICIAN OPTED TO REPLACE THE PT'S IPG WITH A NEW IPG. THE PT WAS RECEIVING EFFECTIVE THERAPY POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69569 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2893990

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention