BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012202 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-12339
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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

    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 EXPERIENCES PAIN AT THE IPG POCKET SITE. IT WAS ALSO REPORTED THE PT HAS NOT USED THE SYSTEM SINCE (B)(6) 2011. THE PT SCHEDULED AN APPOINTMENT WITH THE NEUROSURGEON. A NEW CHARGER WAS SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106205 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3406020

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3228| IMPLANT DATE: