BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141939 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-05739
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    October 5, 2012
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    16278487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS 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

    DEVICE 3 OF 3. REFERENCE MFR. REPORT #: 1627487-2013-05737, # 1627487-2013-05738. IT WAS REPORTED THE PATIENT DID NOT TRUST HIS SCS SYSTEM ANYMORE AFTER RECEIVING THE IPG RECALL LETTER. THE PATIENT ALSO DECLINED REPROGRAMMING DUE TO RECEIVING THE IPG RECALL LETTER. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED. THE EXPLANTED PRODUCT WAS DISPOSED OF BY THE SURGICAL FACILITY. SJM WAS UNAWARE OF THE EXPLANT UNTIL (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233300 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3382984

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention EXPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192