BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2153376 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03144
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG 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 AN SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT PT CLAIMED THE SCS SYSTEM CAUSED PERMANENT DAMAGE TO HER RIGHT FOOT AND LEG. THE PT ALSO ALLEGEDLY CLAIMED THAT HER DOCTOR HAD REVIEWED THE PT'S MRI AND CONFIRMED HER CLAIM. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2810398

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1184 (2)