BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3042330 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-06127
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND 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 PATIENT'S IPG WILL NOT COMMUNICATE WITH EITHER THE CHARGER OR PROGRAMMER. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE IPGS LOSS OF COMMUNICATION. SURGICAL INTERVENTION TO REPLACE THE IPG IS PLANNED AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134841 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2840473

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SCS LEAD, MODEL 3186 (X2)| IMPLANT DATE: