BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921917 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-15040
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-0542011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING #: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2013-15039. THE PT RECEIVED 2 SCS IPGS FROM DIFFERENT LOT NUMBERS. IT WAS REPORTED THE PT IS SCHEDULED TO HAVE AN IPG REPLACED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5408 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2926150

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3342| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3341 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3161 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3159 (2)