BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2241194 · Received August 17, 2011

    Report

    Report Number
    1627487-2011-08073
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SERIAL NUMBER IS ASSOCIATED WITH 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

    THE PT RECEIVED SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED BY THE PT THAT THE IPG POCKET SEEMED LOOSE AND THE IPG FELT LIKE IT COULD FLIP OVER. THE DEVICE WAS STILL IN USE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2897072

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR SCS LEAD: MODEL 3219| IMPLANT: