BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2940573 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-13155
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-13156 AND 13157. THE PT HAS 2 IPG'S FROM DIFFERENT LOT NUMBERS. BOTH DEVICES ARE BEING REPORTED SINCE IT IS UNK WHICH DEVICE WAS RELATED TO THIS EVENT. IT WAS REPORTED THE PT'S LUMBAR SCS SYSTEM HAD NOT BEEN FUNCTIONING FOR A COUPLE OF MONTHS. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41216 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 86635

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention