BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950186 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-23425
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 1, 2012
    Report Date
    June 3, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    FIELD ADVISORIES: 1627487-07262012-002-R, 162487-12192011-003-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 2. REFERENCE MFR. REPORTS # 1627487-2014-23426. THE PATIENT HAD 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION THERAPY DUE TO LEAD MIGRATION. IT WAS ALSO REPORTED THE PATIENT DISCONTINUED USING AND RECHARGING HIS SCS SYSTEM APPROXIMATELY 2 YEARS AGO. AS A RESULT, THE PATIENT'S IPG BECAME INOPERABLE. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 WHERE HIS SCS SYSTEM WAS REMOVED AND REPLACED WITH A NEW ONE. THE PATIENT REPORTED EFFECTIVE THERAPY POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376922 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3058404

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other