BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3182186 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-04773
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    January 23, 2013
    Report Date
    May 23, 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/REMOVAL 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

    IT WAS REPORTED THE PT HAD NOT RECHARGED THE IPG FOR ABOUT 4 MONTHS. THE SJM REP FOUND THE IPG WOULD NOT COMMUNICATE WITH EXTERNAL DEVICES. IT WAS REPORTED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION TO REPLACED THE IPG AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272121 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2796639

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)| SCS ANCHOR, 1194 (2)| IMPLANT DATE: