BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IOG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2548571 · Received April 17, 2012

    Report

    Report Number
    1627487-2012-04513
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD NOT BEEN COMPLIANT WITH CHARGING HER IPG FOR MONTHS AND NO LONGER HAD STIMULATION. THE PT WAS INSTRUCTED TO ATTEMPT TO CHARGE THE IPG. FOLLOW UP IDENTIFIED THE PT WAS TO MEET WITH HER PHYSICIAN REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IOG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2844879

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS LEAD: MODEL 3262 (2)| IMPLANTED: