BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850682 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-26420
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN TWO FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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 HAS NOT USED OR RECHARGED HER IPG IN OVER A YEAR (EXACT DATE UNKNOWN) THE IPG IS UNABLE TO COMMUNICATE WITH THE PROGRAMMER OR CHARGER. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303382 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3229541

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: