BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3222964 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-15931
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-012192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 1 OF 4. REFERENCE MFR REPORT: 1627487-2013-15932, 1627487-2013-15933, 1627487-2013-15934. THE PATIENT HAD 2 EXTENSIONS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED AND REPLACED. REPORTEDLY THE WIRES WERE BROKEN AND DEFECTS IN THE IPG. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316212 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2850514

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other